Dexmedetomidine for Catheter-related Bladder Discomfort

Phase 4

• Conditions: Pain; Blood Pressure; Nausea; Vomiting; Arrhythmia
• Interventions: Drug: Dex infusion; Drug: NS infusion

• Registration Number: NCT01991223
• Lead Sponsor: Seoul National University Hospital

Brief Summary

To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort

Detailed Description

After transurethral bladder resection, large-sized foley catheter have been used for drainage of urine and residual blood. Because of urinary catheterization, patients usually experiences catheter-related bladder discomfort defined as a burning sensation with an urge to void or discomfort in the supra-pubic region caused by catheter- related bladder irritation.

Dexmedetomidine is an alpha-2 antagonist and used as an analgesic agent. The investigators try to evaluate The efficacy of dexmedetomidine for the treatment of catheter-related bladder discomfort

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-19
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Patients scheduled for transurethral bladder resection
• ASA I-III

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Exclusion Criteria

• Patient who disagrees to participate this investigation
• Patient with severe cardiovascular disease
• Patient with small-sized foley catheter (less than 18 Fr.)
• Patinets with any urinary tract obstructions
• Patient with hyperactive or neurogenic bladder
• Patients with chronic renal failure
• Patient with morbidly obese
• Patients with neurogenic disorder
• Patient with medications for chronic pain

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dex group	Dex infusion	DEX infusion will be done during surgery.
Placebo group	NS infusion	NS infusion will be done during surgery.

Primary Outcome Measures

Name	Time	Method
The number of patients with catheter-related bladder discomfort	at postoperative 1 hour	catheter-related bladder discomfort at postoperative 1 hour was evaluated as none, mild, moderate, severe. The number of patients with mild, moderate, severe discomfort will be calculated and compared between groups.

Secondary Outcome Measures

Name	Time	Method
Catheter-related bladder discomfort	at postoperative 0, 1, 6, 24 hours	Catheter-related bladder discomfort will be evaluated as none, mild, moderate, severe at postoperative 0, 1, 6, 24 hours.
Pain at suprapubic area	at postoperative 0, 1, 6, 24 hours	Pain at suprapubic area will be evaluated using NRS (0:none, 100:worst imaginable) at postoperative 0, 1, 6, 24 hours

Trial Locations

Locations (1)

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