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Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation

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ClinicalTrials.gov Identifier: NCT01260662
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : April 29, 2015
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Hennepin Healthcare Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Procedural Sedation
Interventions Drug: Propofol
Drug: 1:1 Propofol/Ketamine
Drug: 4:1 Propofol/Ketamine
Enrollment 271
Recruitment Details 300 patients recruited in the Emergency Department from October 24, 2010 to February 4, 2013
Pre-assignment Details 271 enrolled subjects underwent procedural sedation
Arm/Group Title Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Hide Arm/Group Description

Deep sedation using propofol (10 mg /mL)

Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Period Title: Overall Study
Started 90 85 96
Completed 90 85 96
Not Completed 0 0 0
Arm/Group Title Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine Total
Hide Arm/Group Description

Deep sedation using propofol (10 mg /mL)

Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Total of all reporting groups
Overall Number of Baseline Participants 90 85 96 271
Hide Baseline Analysis Population Description
Baseline Participants include any individual who received drug and underwent procedural sedation.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 90 participants 85 participants 96 participants 271 participants
40
(18 to 83)
39
(18 to 80)
36
(18 to 84)
38
(18 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 85 participants 96 participants 271 participants
Female
43
  47.8%
40
  47.1%
45
  46.9%
128
  47.2%
Male
47
  52.2%
45
  52.9%
51
  53.1%
143
  52.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 90 participants 85 participants 96 participants 271 participants
90 85 96 271
1.Primary Outcome
Title Clinical Interventions During Sedation
Hide Description Add/increase in supplemental oxygen, stimulation to induce respiration, airway repositioning, assisted ventilations, endotracheal intubation
Time Frame From start of sedation procedure to end of sedation procedure, up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm
Arm/Group Title Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Hide Arm/Group Description:

Deep sedation using propofol (10 mg /mL)

Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Overall Number of Participants Analyzed 90 85 96
Measure Type: Number
Unit of Measure: Clinical interventions performed
41 33 48
2.Primary Outcome
Title Hypoxia
Hide Description Pulse oximetry
Time Frame From start of sedation procedure to end of sedation procedure, up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm
Arm/Group Title Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Hide Arm/Group Description:

Deep sedation using propofol (10 mg /mL)

Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Overall Number of Participants Analyzed 90 85 96
Measure Type: Number
Unit of Measure: Patients which experienced hypoxia
11 6 18
3.Secondary Outcome
Title Respiratory Depression
Hide Description Continuous capnographic monitoring
Time Frame From start of sedation procedure to end of sedation procedure, up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm
Arm/Group Title Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Hide Arm/Group Description:

Deep sedation using propofol (10 mg /mL)

Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Overall Number of Participants Analyzed 90 85 96
Measure Type: Number
Unit of Measure: number of respiratory depression events
15 16 21
4.Secondary Outcome
Title Procedural Recall
Hide Description After patients returned to baseline mental status they were asked whether they were able to recall any of the procedure. Question was answered in a yes or no format.
Time Frame Immediately after the end of the procedure, a single time point within 30 minutes of procedures conclusion.
Hide Outcome Measure Data
Hide Analysis Population Description
100 subjects were randomized to each group, 90 subjects in the propofol arm completed the study, 85 in the 1:1 propofol/ketamine arm, and 96 in the 4:1 propofol/ketamine arm
Arm/Group Title Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Hide Arm/Group Description:

Deep sedation using propofol (10 mg /mL)

Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Overall Number of Participants Analyzed 90 85 96
Measure Type: Number
Unit of Measure: percentage report recall of procedure
6 14 11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Hide Arm/Group Description

Deep sedation using propofol (10 mg /mL)

Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)

Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation

All-Cause Mortality
Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/85 (0.00%)   0/96 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Propofol 1:1 Propofol/Ketamine 4:1 Propofol/Ketamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/90 (0.00%)   0/85 (0.00%)   0/96 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Miner
Organization: MinneapolisMRF
Phone: 612-873-3000
EMail: miner015@umn.edu
Layout table for additonal information
Responsible Party: Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT01260662    
Other Study ID Numbers: HSR 10-3230
First Submitted: December 13, 2010
First Posted: December 15, 2010
Results First Submitted: April 10, 2015
Results First Posted: April 29, 2015
Last Update Posted: July 14, 2015