Propofol and Sevoflurane for Catheter-Related Bladder Discomfort

Not Applicable

Completed

• Conditions: Complications; Catheter Site Discomfort; Anesthesia; Urinary Bladder Neoplasms
• Interventions: Drug: Propofol; Drug: Sevoflurane

• Registration Number: NCT02252445
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-09-30
• Study Start: 2014-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-05-02
• Results First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Results First Posted: 2016-09-01
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Propofol will be administered as the anesthetic maintenance agent.
Sevoflurane	Sevoflurane	Sevoflurane will be administered as the anesthetic maintenance agent.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Blurred Vision	0, 1, 6 and 24 hour postoperatively	Blurred vision will be measured at 0, 1, 6 and 24 hour postoperatively.
Dry Mouth	0, 1, 6 and 24 hour postoperatively	Dry mouth will be measured at 0, 1, 6 and 24 hour postoperatively.
Flushing	0, 1, 6 and 24 hour postoperatively	Flushing will be measured at 0, 1, 6 and 24 hour postoperatively.
Dizziness	0, 1, 6 and 24 hour postoperatively	Dizziness will be measured at 0, 1, 6 and 24 hour postoperatively.
Analgesics	0, 1, 6 and 24 hour postoperatively	The amount of analgesics will be measured at 0, 1, 6 and 24 hour postoperatively.
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.
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.
Nausea	0, 1, 6 and 24 hour postoperatively	Nausea will be measured at 0, 1, 6 and 24 hour postoperatively.
Vomiting	0, 1, 6 and 24 hour postoperatively	Vomiting will be measured at 0, 1, 6 and 24 hour postoperatively.

Trial Locations

Locations (1)

Seolu National University of Hospital; 🇰🇷 Seoul, Korea, Republic of