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Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

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ClinicalTrials.gov Identifier: NCT02252445
Recruitment Status : Completed
First Posted : September 30, 2014
Results First Posted : September 1, 2016
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Catheter Site Discomfort
Complications
Anesthesia
Urinary Bladder Neoplasms
Interventions Drug: Propofol
Drug: Sevoflurane
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Period Title: Overall Study
Started 41 41
Completed 41 41
Not Completed 0 0
Arm/Group Title Propofol Sevoflurane Total
Hide Arm/Group Description

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Total of all reporting groups
Overall Number of Baseline Participants 41 41 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  46.3%
19
  46.3%
38
  46.3%
>=65 years
22
  53.7%
22
  53.7%
44
  53.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 41 participants 82 participants
Female
9
  22.0%
11
  26.8%
20
  24.4%
Male
32
  78.0%
30
  73.2%
62
  75.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 41 participants 41 participants 82 participants
41 41 82
1.Primary Outcome
Title Catheter-related Bladder Discomfort
Hide Description 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.
Time Frame 1 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with score >0 were counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
35 24
2.Secondary Outcome
Title Catheter-related Bladder Discomfort
Hide Description 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.
Time Frame 0, 6 and 24 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with score >0 will be counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
38 27
3.Secondary Outcome
Title Hemodynamic Parameters
Hide Description 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.
Time Frame 0, 1, 5, 10 minute postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: mmHg
90  (24) 88  (27)
4.Secondary Outcome
Title Nausea
Hide Description Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame 0, 1, 6 and 24 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with nausea were counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
2 3
5.Secondary Outcome
Title Vomiting
Hide Description Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame 0, 1, 6 and 24 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with vomiting were counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
2 1
6.Secondary Outcome
Title Dry Mouth
Hide Description Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame 0, 1, 6 and 24 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with dry mouth were counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
2 2
7.Secondary Outcome
Title Flushing
Hide Description Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame 0, 1, 6 and 24 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with flushing were counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
0 0
8.Secondary Outcome
Title Blurred Vision
Hide Description Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame 0, 1, 6 and 24 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with blurred vision were counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Dizziness
Hide Description Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame 0, 1, 6 and 24 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with dizziness were counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
0 0
10.Secondary Outcome
Title Analgesics
Hide Description The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame 0, 1, 6 and 24 hour postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
Patients infused with tramadol were counted.
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description:

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

Overall Number of Participants Analyzed 41 41
Measure Type: Number
Unit of Measure: participants
22 13
Time Frame 0 h, 1 h, 6 h, 24 h, 6 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propofol Sevoflurane
Hide Arm/Group Description

Propofol will be administered as the anesthetic maintenance agent.

Propofol: Propofol will be administered.

Sevoflurane will be administered as the anesthetic maintenance agent.

Sevoflurane: Sevoflurane will be administered.

All-Cause Mortality
Propofol Sevoflurane
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Propofol Sevoflurane
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propofol Sevoflurane
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/41 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Assistant professor
Organization: Keimyung university
Phone: +821028862876
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02252445     History of Changes
Other Study ID Numbers: CRBDPPFSEVO
First Submitted: September 26, 2014
First Posted: September 30, 2014
Results First Submitted: May 2, 2016
Results First Posted: September 1, 2016
Last Update Posted: September 1, 2016