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Compare Pharmaceutical Economics and Efficacy of Sevoflurane With Low Fresh Gas Flow Balanced Anesthesia, Propofol Target Controlled Infusion Anesthesia and Propofol Induction Sevoflurane Maintenance Anesthesia

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ClinicalTrials.gov Identifier: NCT01191476
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : July 3, 2012
Last Update Posted : July 3, 2012
Sponsor:
Collaborator:
Rundo International Pharmaceutical Research & Development Co.,Ltd.
Information provided by (Responsible Party):
Abbott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Elective Laparoscopic Surgery
Interventions Drug: Sevoflurane Inhalational Induction and Maintenance
Drug: Propofol Target Controlled Infusion for Induction and Maintenance
Drug: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
Enrollment 336
Recruitment Details Subjects between the ages of 18 and 65 were recruited from 4 hospitals in 4 cities in China. They were required to have elective laparoscopic, in-patient surgery with a predicted anesthetic duration between 1 to 3 hours. Subjects with ASA physical status I or II were enrolled and were to have had the ability to provide informed consent.
Pre-assignment Details The study was a prospective, randomized (1:1:1), open-label, multi-center study comparing the cost of inhalational anesthesia with sevoflurane to intravenous (IV) anesthesia with propofol, or propofol for induction and sevoflurane for maintenance of anesthesia. The full analysis set was used for determination of all primary and secondary endpoints.
Arm/Group Title Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Hide Arm/Group Description Inhalational induction and maintenance anesthesia with sevoflurane. Target controlled infusion anesthesia with propofol for induction and maintenance. Propofol induction and sevoflurane maintenance anesthesia.
Period Title: Overall Study
Started 112 111 [1] 111 [1]
Completed 109 107 111
Not Completed 3 4 0
[1]
Data was not collected for 1 subject for baseline characteristics or the full analysis set.
Arm/Group Title Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance Total
Hide Arm/Group Description Inhalational induction and maintenance anesthesia with sevoflurane. Target controlled infusion anesthesia with propofol for induction and maintenance. Propofol induction and sevoflurane maintenance anesthesia. Total of all reporting groups
Overall Number of Baseline Participants 112 111 111 334
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 111 participants 111 participants 334 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
112
 100.0%
111
 100.0%
111
 100.0%
334
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 111 participants 111 participants 334 participants
42.29  (12.15) 43.26  (12.05) 42.51  (11.81) 42.71  (11.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 111 participants 111 participants 334 participants
Female
92
  82.1%
92
  82.9%
87
  78.4%
271
  81.1%
Male
20
  17.9%
19
  17.1%
24
  21.6%
63
  18.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 112 participants 111 participants 111 participants 334 participants
112 111 111 334
1.Primary Outcome
Title Cost of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevoflurane, Total Intravenous Anesthesia (TIVA) With Propofol, or Intravenous Induction With Propofol and Inhalational Maintenance With Sevoflurane
Hide Description

[Cost of VIMA = unit price of sevoflurane X used volume of sevoflurane];

[Cost of TIVA = unit price of propofol X total volume of propofol in the syringe];

[Cost of Propofol Induction and Sevoflurane Maintenance = unit price of propofol X total volume of propofol in the syringe + unit price of sevoflurane X volume of sevoflurane in the syringe].

The total volume of propofol in the syringe was calculated, even if all the anesthetic was not used, because it could not be reused.

Time Frame Anesthetic Duration between 1 to 3 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set was used for the determination of cost of anesthesia.
Arm/Group Title Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Hide Arm/Group Description:
Inhalational sevoflurane for induction and maintenance of anesthesia
IV Propofol for induction and maintenance of anesthesia
Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Overall Number of Participants Analyzed 112 111 111
Mean (Standard Deviation)
Unit of Measure: Yuan
380.78  (108.53) 548.52  (195.14) 269.40  (74.04)
2.Secondary Outcome
Title Time to Loss of Consciousness
Hide Description Loss of consciousness was measured from the time the anesthetic was administered until loss of consciousness (no response to command) occurred. Inhalational induction was induced with sevoflurane via vital capacity induction at 8%. Intravenous induction was induced with propofol at 4 µg/mL via target controlled infusion (TCI). In subjects who received both anesthetic agents, a bolus dose of propofol 1.5 mg/kg was used for induction.
Time Frame Up to 10 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Hide Arm/Group Description:
Inhalational sevoflurane for induction and maintenance of anesthesia
IV propofol for induction and maintenance of anesthesia
Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Overall Number of Participants Analyzed 112 111 111
Mean (Standard Deviation)
Unit of Measure: seconds
48.54  (22.77) 100.32  (55.15) 68.76  (34.96)
3.Secondary Outcome
Title Time to Eye Opening
Hide Description Measured from the time sevoflurane or propofol administration was stopped until the subject's eyes were opened. The investigator tapped the subject on the forehead or shoulder after anesthesia was stopped and asked them to open their eyes. This process was repeated approximately every minute until eye opening occurred.
Time Frame Every minute after anesthesia was stopped until the subjects' eyes opened
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Hide Arm/Group Description:
Inhalational sevoflurane for induction and maintenance of anesthesia
IV propofol for induction and maintenance of anesthesia
Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Overall Number of Participants Analyzed 112 111 111
Mean (Standard Deviation)
Unit of Measure: Minutes
8.38  (3.66) 9.79  (6.92) 8.69  (3.50)
4.Secondary Outcome
Title Time to Extubation
Hide Description Time to extubation was measured from the time sevoflurane or propofol administration was stopped until tracheal extubation occurred. Criteria to determine extubation included a train of four stimulus > 0.9 (a method to measure the magnitude and type of neuromuscular block, a ratio of the fourth response to the first one), a tidal volume > 5 mL/kg, minute ventilation > 3 L, a respiratory rate of > 10 breaths/minute, an end tidal carbon dioxide < 45 mmHg, and eye opening has occurred.
Time Frame Every minute after anesthesia was stopped until extubation occurred
Hide Outcome Measure Data
Hide Analysis Population Description
Measurement
Arm/Group Title Sevoflurane Propofol Propofol Induction and Sevoflurane Maintenance
Hide Arm/Group Description:
Inhalational sevoflurane for induction and maintenance of anesthesia
IV propofol for induction and maintenance of anesthesia
Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Overall Number of Participants Analyzed 112 111 111
Mean (Standard Deviation)
Unit of Measure: Minutes
9.69  (3.84) 11.32  (6.91) 9.79  (3.52)
5.Secondary Outcome
Title Time to Orientation
Hide Description Time to orientation was measured from the time sevoflurane or propofol administration was stopped until orientation (able to state their name and date of birth).
Time Frame Every minute after anesthesia was stopped until orientation occurred
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Hide Arm/Group Description:
Inhalational sevoflurane for induction and maintenance of anesthesia
IV propofol for induction and maintenance of anesthesia
Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
Overall Number of Participants Analyzed 112 111 111
Mean (Standard Deviation)
Unit of Measure: Minutes
13.97  (6.73) 17.64  (12.45) 14.95  (6.39)
Time Frame All adverse events were reported from the time study drug was administered until 30 days after the study drug treatment was completed. Serious adverse events were collected from the time the subject signed the informed consent form.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Hide Arm/Group Description Inhalational induction and maintenance anesthesia with sevoflurane. Target controlled infusion anesthesia with propofol for induction and maintenance. Propofol induction and sevoflurane maintenance anesthesia.
All-Cause Mortality
Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)   0/111 (0.00%)   0/111 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sevoflurane Propofol Propofol Induction Sevoflurane Maintenance
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/112 (4.46%)   4/111 (3.60%)   5/111 (4.50%) 
Cardiac disorders       
bradycardia  1  3/112 (2.68%)  0/111 (0.00%)  1/111 (0.90%) 
Investigations       
diastolic blood pressure decreased  1  0/112 (0.00%)  0/111 (0.00%)  1/111 (0.90%) 
Nervous system disorders       
Movement Disorder  1  0/112 (0.00%)  1/111 (0.90%)  0/111 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/112 (0.00%)  1/111 (0.90%)  0/111 (0.00%) 
Vascular disorders       
hypotension  1  3/112 (2.68%)  2/111 (1.80%)  2/111 (1.80%) 
Hypertension  1  0/112 (0.00%)  0/111 (0.00%)  1/111 (0.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: Abbott
Phone: 800-633-9110
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01191476     History of Changes
Other Study ID Numbers: R12-564
First Submitted: August 27, 2010
First Posted: August 30, 2010
Results First Submitted: May 31, 2012
Results First Posted: July 3, 2012
Last Update Posted: July 3, 2012