Trial Outcomes & Findings for Pain After Laparoscopic Cholecystectomy (NCT NCT00983918)
NCT ID: NCT00983918
Last Updated: 2019-02-01
Results Overview
Pain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
24 hours
Results posted on
2019-02-01
Participant Flow
Recruitment from September 23, 2009 to March 9, 2010/
Participant milestones
| Measure |
Desflurane
General Anesthesia with Desflurane
|
Sevoflurane
General Anesthesia with Sevoflurane
|
Isoflurane
General Anesthesia with Isoflurane
|
Propofol
General Anesthesia with Propofol
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
18
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Desflurane
General Anesthesia with Desflurane
|
Sevoflurane
General Anesthesia with Sevoflurane
|
Isoflurane
General Anesthesia with Isoflurane
|
Propofol
General Anesthesia with Propofol
|
|---|---|---|---|---|
|
Overall Study
conversion to open cholecystectomy
|
0
|
2
|
2
|
2
|
Baseline Characteristics
Pain After Laparoscopic Cholecystectomy
Baseline characteristics by cohort
| Measure |
Desflurane
n=20 Participants
General Anesthesia with Desflurane
|
Sevoflurane
n=20 Participants
General Anesthesia with Sevoflurane
|
Isoflurane
n=20 Participants
General Anesthesia with Isoflurane
|
Propofol
n=20 Participants
General Anesthesia with Propofol
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
20 Participants
n=157 Participants
|
80 Participants
n=390 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 12 • n=99 Participants
|
34 years
STANDARD_DEVIATION 14 • n=107 Participants
|
34 years
STANDARD_DEVIATION 12 • n=206 Participants
|
29 years
STANDARD_DEVIATION 7 • n=157 Participants
|
33 years
STANDARD_DEVIATION 11 • n=390 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
18 Participants
n=157 Participants
|
63 Participants
n=390 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
17 Participants
n=390 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
20 participants
n=206 Participants
|
20 participants
n=157 Participants
|
80 participants
n=390 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPain measured on verbal scale of 0-10, with 0 being absolutely no pain, and 10 being the worst pain in that subjects life.
Outcome measures
| Measure |
Desflurane
n=20 Participants
General Anesthesia with Desflurane
|
Sevoflurane
n=18 Participants
General Anesthesia with Sevoflurane
|
Isoflurane
n=18 Participants
General Anesthesia with Isoflurane
|
Propofol
n=18 Participants
General Anesthesia with Propofol
|
|---|---|---|---|---|
|
Pain Measured on Verbal Scale of 0-10
|
2.7 units on a scale
Standard Deviation 3.2
|
1.7 units on a scale
Standard Deviation 2.4
|
3 units on a scale
Standard Deviation 2.5
|
2.1 units on a scale
Standard Deviation 1.4
|
Adverse Events
Desflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sevoflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Isoflurane
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place