Sevoflurane Versus Desflurane for Catheter-related Bladder Discomfort

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02096224
• Collaborator: (none)
• Enrollment: 108
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 53.9

Study Details

Study Description

Brief Summary

We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of catheter-related bladder discomfort.

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

Detailed Description

The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. The volatile anesthetics such as sevoflurane and desflurane are known to block the muscarinic receptor in different ways.

We want to evaluate the efficacy of the sevoflurane and desflurane for the prevention of catheter-related bladder discomfort.

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comparison of the Effects of Sevoflurane and Desflurane on Prevention of Catheter-related Bladder Discomfort
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevoflurane Sevoflurane will be administered as the maintenance agent of general anesthesia.	Drug: Sevoflurane; Sevoflurane will be used.
Active Comparator: Desflurane Desflurane will be administered as the maintenance agent of general anesthesia.	Drug: Desflurane; Desflurane will be used

Outcome Measures

Primary Outcome Measures

1. Catheter-related bladder discomfort [24 hour postoperatively]

   Catheter-related bladder discomfort will be measured for 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).

Secondary Outcome Measures

1. Catheter-related bladder discomfort [0, 1, 6 and 24 hour postoperatively]

   Catheter-related bladder discomfort will be measured at 0, 1, 6 and 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe).

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

   The degree of nausea will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.

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

   The degree of vomiting will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively.

4. Dry mouth [0 houe after admission of operating room]

   Dry mouth after the admission of operating room will be assessed. (score:0-10)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 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:

• Bladder outflow obstruction

• Overactive bladder

• End-stage renal disease

• Neurogenic bladder

• Heart failure

• Arrhythmia

• Morbid obesity

• Use of chronic analgesic medication

• Hepatic disease

• Pulmonary disease

• Psychiatric disease

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Study Chair: Hee-Pyoung Park, PhD, Seoul National University of Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02096224
• Other Study ID Numbers: CRBDSevoDes
• First Posted: Mar 26, 2014
• Last Update Posted: Oct 2, 2014
• Last Verified: Mar 1, 2014

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

Study Results

No Results Posted as of Oct 2, 2014