Trial Outcomes & Findings for Propofol and Sevoflurane for Catheter-Related Bladder Discomfort (NCT NCT02252445)
NCT ID: NCT02252445
Last Updated: 2016-09-01
Results Overview
Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score \>0 will be counted.
COMPLETED
NA
82 participants
1 hour postoperatively
2016-09-01
Participant Flow
Participant milestones
| Measure |
Propofol
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
41
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Propofol and Sevoflurane for Catheter-Related Bladder Discomfort
Baseline characteristics by cohort
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
41 participants
n=5 Participants
|
41 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hour postoperativelyPopulation: Patients with score \>0 were counted.
Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score \>0 will be counted.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Catheter-related Bladder Discomfort
|
35 participants
|
24 participants
|
SECONDARY outcome
Timeframe: 0, 6 and 24 hour postoperativelyPopulation: Patients with score \>0 will be counted.
Catheter-related bladder discomfort will be measured at 1 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). Patients with score \>0 will be counted.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Catheter-related Bladder Discomfort
|
38 participants
|
27 participants
|
SECONDARY outcome
Timeframe: 0, 1, 5, 10 minute postoperativelyMean blood pressure and heart rate will be measured at 0, 1, 5, 10 minute postoperatively. Measurement at 10 minute means Mean blood pressure and heart rate at the admission of post-anesthetic care unit.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Hemodynamic Parameters
|
90 mmHg
Standard Deviation 24
|
88 mmHg
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 0, 1, 6 and 24 hour postoperativelyPopulation: Patients with nausea were counted.
Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Nausea
|
2 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 0, 1, 6 and 24 hour postoperativelyPopulation: Patients with vomiting were counted.
Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Vomiting
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 0, 1, 6 and 24 hour postoperativelyPopulation: Patients with dry mouth were counted.
Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Dry Mouth
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 0, 1, 6 and 24 hour postoperativelyPopulation: Patients with flushing were counted.
Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Flushing
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0, 1, 6 and 24 hour postoperativelyPopulation: Patients with blurred vision were counted.
Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Blurred Vision
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0, 1, 6 and 24 hour postoperativelyPopulation: Patients with dizziness were counted.
Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Dizziness
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 0, 1, 6 and 24 hour postoperativelyPopulation: Patients infused with tramadol were counted.
The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
Outcome measures
| Measure |
Propofol
n=41 Participants
Propofol will be administered as the anesthetic maintenance agent.
Propofol: Propofol will be administered.
|
Sevoflurane
n=41 Participants
Sevoflurane will be administered as the anesthetic maintenance agent.
Sevoflurane: Sevoflurane will be administered.
|
|---|---|---|
|
Analgesics
|
22 participants
|
13 participants
|
Adverse Events
Propofol
Sevoflurane
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