Postoperative Pain
Conditions
Brief summary
To the investigators' knowledge, no study has looked at differences in postoperative pain when comparing maintenance of anesthesia with isoflurane, desflurane, sevoflurane, and propofol in laparoscopic cholecystectomy. The investigators' hypothesis is that total intravenous anesthesia with propofol will lead to less postoperative pain in the first 24 hours after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane or sevoflurane. PURPOSE To find out if maintenance of anesthesia with propofol leads to less postoperative pain after laparoscopic cholecystectomy when compared to maintenance of anesthesia with isoflurane, desflurane, or sevoflurane.
Interventions
DRUGDesflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Desflurane
DRUGSevoflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Sevoflurane
DRUGIsoflurane
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with Isoflurane
DRUGPropofol
Patient induced for general anesthesia as per standard protocol and maintenance of anesthesia provided with intravenous Propofol infusion
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. Patient ages 18-64 2. American Society of Anesthesiology Physical Status I, II or III 3. Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital
Exclusion criteria
1. Open cholecystectomy - excluded due to increased levels of pain in open procedures 2. Scheduled for ambulatory surgery 3. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications 4. Allergy to any of the study medications or anesthetic agents 5. Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone 6. Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder) 7. Patient or surgeon refusal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measured on Verbal Scale of 0-10 | 24 hours | Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life. |
Countries
United States
Participant flow
Recruitment details
Recruitment from September 23, 2009 to March 9, 2010/
Participants by arm
| Arm | Count |
|---|---|
| Desflurane General Anesthesia with Desflurane | 20 |
| Sevoflurane General Anesthesia with Sevoflurane | 20 |
| Isoflurane General Anesthesia with Isoflurane | 20 |
| Propofol General Anesthesia with Propofol | 20 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | conversion to open cholecystectomy | 0 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Sevoflurane | Isoflurane | Desflurane | Propofol | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 80 Participants |
| Age, Continuous | 34 years STANDARD_DEVIATION 14 | 34 years STANDARD_DEVIATION 12 | 33 years STANDARD_DEVIATION 12 | 29 years STANDARD_DEVIATION 7 | 33 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 14 Participants | 18 Participants | 63 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 6 Participants | 2 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 18 | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Pain Measured on Verbal Scale of 0-10
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Desflurane | Pain Measured on Verbal Scale of 0-10 | 2.7 units on a scale | Standard Deviation 3.2 |
| Sevoflurane | Pain Measured on Verbal Scale of 0-10 | 1.7 units on a scale | Standard Deviation 2.4 |
| Isoflurane | Pain Measured on Verbal Scale of 0-10 | 3 units on a scale | Standard Deviation 2.5 |
| Propofol | Pain Measured on Verbal Scale of 0-10 | 2.1 units on a scale | Standard Deviation 1.4 |