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Pain After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT00983918
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : March 11, 2014
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jaime Ortiz, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Postoperative Pain
Interventions Drug: Desflurane
Drug: Sevoflurane
Drug: Isoflurane
Drug: Propofol
Enrollment 80
Recruitment Details Recruitment from September 23, 2009 to March 9, 2010/
Pre-assignment Details  
Arm/Group Title Desflurane Sevoflurane Isoflurane Propofol
Hide Arm/Group Description General Anesthesia with Desflurane General Anesthesia with Sevoflurane General Anesthesia with Isoflurane General Anesthesia with Propofol
Period Title: Overall Study
Started 20 20 20 20
Completed 20 18 18 18
Not Completed 0 2 2 2
Reason Not Completed
conversion to open cholecystectomy             0             2             2             2
Arm/Group Title Desflurane Sevoflurane Isoflurane Propofol Total
Hide Arm/Group Description General Anesthesia with Desflurane General Anesthesia with Sevoflurane General Anesthesia with Isoflurane General Anesthesia with Propofol Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 20 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
20
 100.0%
20
 100.0%
80
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
33  (12) 34  (14) 34  (12) 29  (7) 33  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
Female
14
  70.0%
15
  75.0%
16
  80.0%
18
  90.0%
63
  78.8%
Male
6
  30.0%
5
  25.0%
4
  20.0%
2
  10.0%
17
  21.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 20 participants 20 participants 80 participants
20 20 20 20 80
1.Primary Outcome
Title Pain Measured on Verbal Scale of 0-10
Hide Description Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Desflurane Sevoflurane Isoflurane Propofol
Hide Arm/Group Description:
General Anesthesia with Desflurane
General Anesthesia with Sevoflurane
General Anesthesia with Isoflurane
General Anesthesia with Propofol
Overall Number of Participants Analyzed 20 18 18 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (3.2) 1.7  (2.4) 3  (2.5) 2.1  (1.4)
2.Secondary Outcome
Title Analgesic Consumption
Hide Description [Not Specified]
Time Frame 24 hours
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desflurane Sevoflurane Isoflurane Propofol
Hide Arm/Group Description General Anesthesia with Desflurane General Anesthesia with Sevoflurane General Anesthesia with Isoflurane General Anesthesia with Propofol
All-Cause Mortality
Desflurane Sevoflurane Isoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Desflurane Sevoflurane Isoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/18 (0.00%)   0/18 (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 1%
Desflurane Sevoflurane Isoflurane Propofol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jaime Ortiz, MD
Organization: Baylor College of Medicine
Phone: 713-873-2860
Responsible Party: Jaime Ortiz, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00983918     History of Changes
Other Study ID Numbers: H-24815
First Submitted: September 22, 2009
First Posted: September 24, 2009
Results First Submitted: February 14, 2012
Results First Posted: March 11, 2014
Last Update Posted: February 14, 2018