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Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)

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ClinicalTrials.gov Identifier: NCT00436345
Recruitment Status : Terminated (recruitment issues)
First Posted : February 19, 2007
Results First Posted : May 18, 2010
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Analgesia
Interventions Drug: Remifentanil
Drug: Propofol
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate. The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Period Title: Overall Study
Started 21 18
Completed 18 18
Not Completed 3 0
Reason Not Completed
ICU resident beyond follow-up period             3             0
Arm/Group Title Remifentanil Propofol Total
Hide Arm/Group Description Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate. The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols. Total of all reporting groups
Overall Number of Baseline Participants 21 18 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 18 participants 39 participants
62.1  (10.7) 60.2  (14.3) 61.23  (12.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
Female
11
  52.4%
7
  38.9%
18
  46.2%
Male
10
  47.6%
11
  61.1%
21
  53.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 21 participants 18 participants 39 participants
White 21 17 38
Asian 0 1 1
Simplified acute physiology score (SAPS II) score   [1] 
Mean (Standard Deviation)
Unit of measure:  Points on a scale
Number Analyzed 21 participants 18 participants 39 participants
25.7  (16.7) 20.9  (16.1) 23.23  (16.30)
[1]
Measure Description: The SAPS II score consists of adding the points from 17 variables: age, 12 physiological variables, type of admission, and 3 chronic disease variables. These variables are added to give a SAPS II score with a range of 0 ("predicted mortality" 0%) to 163 ("predicted mortality" 100%). SAPS II data were collected from local laboratories for 24 hours following ICU admission.
1.Primary Outcome
Title Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
Hide Description Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).
Time Frame Up to 38 days (912 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all randomised participants who had taken at least one dose of study medication
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 21 18
Mean (Standard Error)
Unit of Measure: Hours (hr)
77  (8.31) 70  (6.48)
2.Primary Outcome
Title Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)
Hide Description Time from start of mechanical ventilation until actual extubation.
Time Frame Up to 38 days (912 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified-Intent-to-Treat (mITT) Population: all randomised participants who had taken at least one dose of study medication and who had efficacy measurements
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 21 18
Mean (Standard Error)
Unit of Measure: Hours
77  (8.31) 70  (6.48)
3.Primary Outcome
Title Duration of Time on Mechanical Ventilation (Per-Protocol Population)
Hide Description Time from start of mechanical ventilation until actual extubation
Time Frame Up to 38 days (912 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol (PP) Population: all participants from the MITT population without any major protocol violation
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 11 13
Mean (Standard Error)
Unit of Measure: Hours
87  (9.47) 81  (4.71)
4.Secondary Outcome
Title Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator’s Decision)
Hide Description Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
Time Frame Up to 38 days (912 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with available ICU data were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 12 14
Mean (Standard Deviation)
Unit of Measure: Hours
Duration of ICU stay 212.6  (163.4) 208.5  (185.2)
Duration of potential ICU stay 211.3  (161.4) 208.1  (185.1)
5.Secondary Outcome
Title Duration of Extubation
Hide Description Duration of extubation was measured.
Time Frame up to 38 days (912 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants with available extubation data were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 13 12
Mean (Standard Deviation)
Unit of Measure: hours
0.4  (0.5) 0.7  (0.8)
6.Secondary Outcome
Title Duration of Weaning
Hide Description Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
Time Frame up to 38 days (912 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants for which data are available were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 19 14
Mean (Standard Deviation)
Unit of Measure: hours
0.42  (1.0) 0.26  (0.3)
7.Secondary Outcome
Title Duration of Remifentanil Infusion (ITT Population)
Hide Description Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame Up to 10 days (240 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants infused with Remifentanil were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 21 0
Mean (Standard Deviation)
Unit of Measure: Hours
67.7  (60.3)
8.Secondary Outcome
Title Duration of Propofol Infusion (ITT Population)
Hide Description Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame up to 10 days (240 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants infused with Propofol were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 13 18
Mean (Standard Deviation)
Unit of Measure: hours
47.6  (41.8) 86.2  (89.4)
9.Secondary Outcome
Title Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
Hide Description Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame up to 10 days (240 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants infused with Sufentanil, Fentanil, and Morphine were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 0 8
Mean (Standard Deviation)
Unit of Measure: hours
Sufentanil, n=8 51.2  (15.42)
Fentanil, n=5 47.5  (40.7)
Morphine, n=1 0.03  (0.0)
10.Secondary Outcome
Title Dose of Remifentanil Administered – Continuous Infusion
Hide Description Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants dosed with Remifentanil were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 21 0
Mean (Standard Deviation)
Unit of Measure: ug/kg/h (micrograms per kilogram per hr)
10.6  (7.2)
11.Secondary Outcome
Title Doses of Sufentanil and Fentanil Administered – Continuous Infusion
Hide Description Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants dosed with Remifentanil were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 0 8
Mean (Standard Deviation)
Unit of Measure: ug/kg/h
Sufentanil, n=8 0.2  (0.1)
Fentanil, n=5 5.0  (7.5)
12.Secondary Outcome
Title Dose of Propofol Administered – Continuous Infusion
Hide Description Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants dosed with Propofol were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 13 18
Mean (Standard Deviation)
Unit of Measure: mg/kg/h (milligrams per kilogram per hr)
2.3  (4.0) 1.8  (1.3)
13.Secondary Outcome
Title Dose of Morphine Administered – Continuous Infusion
Hide Description Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants dosed with Morphine were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 0 1
Mean (Standard Deviation)
Unit of Measure: mg/kg/h
4.3  (0.0)
14.Secondary Outcome
Title Total Dose of Propofol Administered - Bolus
Hide Description Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants dosed with Propofol were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: mg/kg
1.5  (0.4) 5.5  (4.5)
15.Secondary Outcome
Title Total Dose of Fentanil Administered - Bolus
Hide Description Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
Time Frame Up to 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only participants dosed with Fentanil were analyzed.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 0 5
Mean (Standard Deviation)
Unit of Measure: ug/kg
5.1  (3.6)
16.Secondary Outcome
Title Number of Participants Analyzed for Sedation – Agitation Scale (SAS) and Pain Intensity (PI) Scale
Hide Description Data from participants in the study for which the Sedation–Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. “Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. “Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Time Frame Up to 38 Days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT Population
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 21 18
Measure Type: Number
Unit of Measure: participants
Screening period 21 18
Day 1 21 18
Day 2 18 17
Day 3 15 14
Day 4 10 11
Day 5 6 3
Day 6 2 2
Day 7 2 1
Day 8 1 0
Day 9 1 0
Day 10 1 0
Extubation period 12 12
Post-extubation period 5 6
17.Secondary Outcome
Title Sedation-Agitation From Screening Through the End of Study
Hide Description "Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Time Frame Up to 38 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT Population, according to the participants’ status
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: Points on a scale
Screening period 3.5  (1.0) 3.7  (1.2)
Day 1 3.0  (0.9) 2.9  (0.8)
Day 2 2.8  (1.0) 2.9  (0.9)
Day 3 3.1  (0.8) 3.1  (0.6)
Day 4 3.4  (0.9) 3.1  (0.6)
Day 5 3.5  (0.4) 3.1  (1.1)
Day 6 3.9  (0.2) 2.6  (0.6)
Extubation period 3.2  (0.7) 3.6  (0.4)
Post-extubation period 3.8  (0.8) 4.0  (0.0)
18.Secondary Outcome
Title Sedation-Agitation for Day 7
Hide Description “Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Time Frame Day 7
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT Population according to the participants’ status
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 1 1
Mean (Standard Deviation)
Unit of Measure: points on a scale
4.0  (0.0) 3.3  (0.0)
19.Secondary Outcome
Title Sedation-Agitation From Day 8 to Day 10
Hide Description “Sedation - Agitation” was assessed, using the “Riker Sedation-Agitation Scale” (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable.
Time Frame Days 8, 9, and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT Population according to the participants’ status
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: points on a scale
Day 8 4.0  (0.0)
Day 9 3.3  (0.0)
Day 10 3.6  (0.0)
20.Secondary Outcome
Title Number of Participants Analyzed for BIS (Bispectral Index Scale)
Hide Description Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Time Frame Up to 38 days
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Hide Analysis Population Description
mITT Population
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 5 0
Measure Type: Number
Unit of Measure: participants
Screening period 3
Day 1 4
Day 2 4
Day 3 5
Day 4 4
Day 5 1
Day 6 0
Day 7 0
Day 8 0
Day 9 0
Day 10 0
Extubation period 2
Post-extubation period 2
21.Secondary Outcome
Title Bispectral Index (BIS)
Hide Description The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Time Frame Screening through End of Study, up to 38 days
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Hide Analysis Population Description
mITT Population. Due to the nonmandatory nature of BIS measure in the clinical practice, some participants did not have all the measures for all days in which they were in the study.
Arm/Group Title Remifentanil
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per killograms per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: Points on a scale
Screening period (n = 3, 0) 38.0  (4.6)
Day 1 (n = 4, 0) 47.3  (18.3)
Day 2 (n = 4, 0) 45.6  (16.8)
Day 3 (n = 5, 0) 45.8  (17.5)
Day 4 (n = 4, 0) 49.7  (13.3)
22.Secondary Outcome
Title Bispectral Index (BIS) for Day 5
Hide Description The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Time Frame Day 5
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Hide Analysis Population Description
mITT Population. At Day 5, only one participant remained in the study; the others were already extubated.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: points on a scale
52.7  (0.0)
23.Secondary Outcome
Title Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
Hide Description The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia.
Time Frame up to 38 days
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Hide Analysis Population Description
mITT Population. The BIS value was recorded only for 2 participants, in the extubation and post-extubation periods.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 2 0
Mean (Standard Deviation)
Unit of Measure: points on a scale
Extubation period 70.0  (0.0)
Post-Extubation period 71.8  (1.1)
24.Secondary Outcome
Title Pain Intensity (PI)
Hide Description “Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Time Frame Up to 38 days
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Hide Analysis Population Description
ITT Population, according to the participants' status. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: Points on a scale
Screening period, n=21, 18 1.3  (0.8) 1.2  (0.5)
Day 1, n=21, 18 1.3  (0.5) 1.1  (0.2)
Day 2, n=18, 17 1.2  (0.4) 1.1  (0.2)
Day 3, n=15, 14 1.2  (0.4) 1.1  (0.3)
Day 4, n=10, 11 1.2  (0.4) 1.0  (0.1)
Day 5, n=6, 3 1.3  (0.7) 1.0  (0.0)
Day 6, n=2, 2 1.0  (0.0) 1.0  (0.0)
Day 7, n=2, 1 1.0  (0.0) 1.0  (0.0)
Extubation period, n=12, 12 1.4  (0.8) 1.4  (0.6)
Post-extubation period, n=5, 6 2.0  (1.0) 1.3  (0.5)
25.Secondary Outcome
Title Pain Intensity From Day 8 to Day 10
Hide Description “Pain Intensity” was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain.
Time Frame Days 8, 9, and 10
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Hide Analysis Population Description
mITT Population. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day.
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description:
Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
Overall Number of Participants Analyzed 1 0
Mean (Standard Deviation)
Unit of Measure: points on a scale
Day 8 1.0  (0.0)
Day 9 1.0  (0.0)
Day 10 1.0  (0.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Remifentanil Propofol
Hide Arm/Group Description Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate. The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
All-Cause Mortality
Remifentanil Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Remifentanil Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Remifentanil Propofol
Affected / at Risk (%) Affected / at Risk (%)
Total   6   3 
Cardiac disorders     
Bradycardia  1  0/21 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Ascites  1  1/21 (4.76%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Apnoea  1  2/21 (9.52%)  0/18 (0.00%) 
Respiratory depression  1  1/21 (4.76%)  0/18 (0.00%) 
Respiratory failure  1  1/21 (4.76%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders     
Oedema at surgical site  1  0/21 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Hypertension  1  5/21 (23.81%)  1/18 (5.56%) 
Hypotension  1  2/21 (9.52%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00436345     History of Changes
Other Study ID Numbers: 108701
First Submitted: February 15, 2007
First Posted: February 19, 2007
Results First Submitted: August 7, 2009
Results First Posted: May 18, 2010
Last Update Posted: May 30, 2017