Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02252445
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 40.9

Study Details

Study Description

Brief Summary

The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Condition or Disease	Intervention/Treatment	Phase
Catheter Site Discomfort; Complications; Anesthesia; Urinary Bladder Neoplasms	Drug: Propofol; Drug: Sevoflurane	N/A

Detailed Description

The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent. Propofol and desflurane are known to block the muscarinic receptor in different ways.

The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Propofol and Sevoflurane on Postoperative Catheter-Related Bladder Discomfort
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Propofol Propofol will be administered as the anesthetic maintenance agent.	Drug: Propofol; Propofol will be administered.
Experimental: Sevoflurane Sevoflurane will be administered as the anesthetic maintenance agent.	Drug: Sevoflurane; Sevoflurane will be administered.

Outcome Measures

Primary Outcome Measures

1. Catheter-related Bladder Discomfort [1 hour postoperatively]

   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.

Secondary Outcome Measures

1. Catheter-related Bladder Discomfort [0, 6 and 24 hour postoperatively]

   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.

2. Hemodynamic Parameters [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.

3. Nausea [0, 1, 6 and 24 hour postoperatively]

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

4. Vomiting [0, 1, 6 and 24 hour postoperatively]

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

5. Dry Mouth [0, 1, 6 and 24 hour postoperatively]

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

6. Flushing [0, 1, 6 and 24 hour postoperatively]

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

7. Blurred Vision [0, 1, 6 and 24 hour postoperatively]

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

8. Dizziness [0, 1, 6 and 24 hour postoperatively]

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

9. Analgesics [0, 1, 6 and 24 hour postoperatively]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled for transurethral bladder excision under general anesthesia

• ASA I-III

Exclusion Criteria:

• Foley catheter less than 18 Fr.

• Patients with obstruction of urinary tract

• Patients with neurogenic bladder

• Patients with severe obesity

• Patients with neurologic disorder

• Patients with chronic pain

• Patients with allergic history to propofol or sevoflurane

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seolu National University of Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02252445
• Other Study ID Numbers: CRBDPPFSEVO
• First Posted: Sep 30, 2014
• Last Update Posted: Sep 1, 2016
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Propofol; Sevoflurane

Study Results

Participant Flow

Arm/Group Title	Propofol	Sevoflurane
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

Baseline Characteristics

Arm/Group Title	Propofol	Sevoflurane	Total
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 Participants	41	41	82
Age (Count of Participants)
<=18 years	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 (Count of Participants)
Female	9 22%	11 26.8%	20 24.4%
Male	32 78%	30 73.2%	62 75.6%
Region of Enrollment (participants) [Number]
Korea, Republic of	41 100%	41 100%	82 100%

Outcome Measures

1. Primary Outcome

Title	Catheter-related Bladder Discomfort
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

Outcome Measure Data

Analysis Population Description

Patients with score >0 were counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	35 85.4%	24 58.5%

2. Secondary Outcome

Title	Catheter-related Bladder Discomfort
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

Outcome Measure Data

Analysis Population Description

Patients with score >0 will be counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	38 92.7%	27 65.9%

3. Secondary Outcome

Title	Hemodynamic Parameters
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Mean (Standard Deviation) [mmHg]	90 (24)	88 (27)

4. Secondary Outcome

Title	Nausea
Description	Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame	0, 1, 6 and 24 hour postoperatively

Outcome Measure Data

Analysis Population Description

Patients with nausea were counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	2 4.9%	3 7.3%

5. Secondary Outcome

Title	Vomiting
Description	Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame	0, 1, 6 and 24 hour postoperatively

Outcome Measure Data

Analysis Population Description

Patients with vomiting were counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	2 4.9%	1 2.4%

6. Secondary Outcome

Title	Dry Mouth
Description	Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame	0, 1, 6 and 24 hour postoperatively

Outcome Measure Data

Analysis Population Description

Patients with dry mouth were counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	2 4.9%	2 4.9%

7. Secondary Outcome

Title	Flushing
Description	Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame	0, 1, 6 and 24 hour postoperatively

Outcome Measure Data

Analysis Population Description

Patients with flushing were counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	0 0%	0 0%

8. Secondary Outcome

Title	Blurred Vision
Description	Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame	0, 1, 6 and 24 hour postoperatively

Outcome Measure Data

Analysis Population Description

Patients with blurred vision were counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	0 0%	0 0%

9. Secondary Outcome

Title	Dizziness
Description	Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
Time Frame	0, 1, 6 and 24 hour postoperatively

Outcome Measure Data

Analysis Population Description

Patients with dizziness were counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	0 0%	0 0%

10. Secondary Outcome

Title	Analgesics
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

Outcome Measure Data

Analysis Population Description

Patients infused with tramadol were counted.

Arm/Group Title	Propofol	Sevoflurane
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.
Measure Participants	41	41
Number [participants]	22 53.7%	13 31.7%

Adverse Events

Time Frame	0 h, 1 h, 6 h, 24 h, 6 month
Arm/Group Title	Propofol		Sevoflurane
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Propofol		Sevoflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Propofol		Sevoflurane
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.