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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02096224
Other study ID # CRBDSevoDes
Secondary ID
Status Completed
Phase N/A
First received March 21, 2014
Last updated September 30, 2014
Start date May 2014
Est. completion date July 2014

Study information

Verified date March 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Drug:
Sevoflurane
Sevoflurane will be used.
Desflurane
Desflurane will be used

Locations

Country Name City State
Korea, Republic of Seoul National University of Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Catheter-related bladder discomfort Catheter-related bladder discomfort will be measured for 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). 24 hour postoperatively No
Secondary Catheter-related bladder discomfort Catheter-related bladder discomfort will be measured at 0, 1, 6 and 24 hour postoperatively (0:none, 1:mild, 2:moderate, 3:severe). 0, 1, 6 and 24 hour postoperatively No
Secondary Nausea The degree of nausea will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6 and 24 hour postoperatively No
Secondary Vomiting The degree of vomiting will be assessed as none, mild, moderate and severe at 0, 1, 6 and 24 hour postoperatively. 0, 1, 6 and 24 hour postoperatively No
Secondary Dry mouth Dry mouth after the admission of operating room will be assessed. (score:0-10) 0 houe after admission of operating room No
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