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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

82 participants

Primary outcome timeframe

1 hour postoperatively

Results posted on

2016-09-01

Participant Flow

Participant milestones

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

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 postoperatively

Population: 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

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 postoperatively

Population: 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

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 postoperatively

Mean 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

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 postoperatively

Population: Patients with nausea were counted.

Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.

Outcome measures

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 postoperatively

Population: Patients with vomiting were counted.

Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.

Outcome measures

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 postoperatively

Population: Patients with dry mouth were counted.

Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.

Outcome measures

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 postoperatively

Population: Patients with flushing were counted.

Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.

Outcome measures

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 postoperatively

Population: Patients with blurred vision were counted.

Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.

Outcome measures

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 postoperatively

Population: Patients with dizziness were counted.

Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.

Outcome measures

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 postoperatively

Population: Patients infused with tramadol were counted.

The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.

Outcome measures

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

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assistant professor

Keimyung university

Phone: +821028862876

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place