Dexmedetomidine for Catheter-related Bladder Discomfort

Pain Clinical Trial

— CRBDEX  

Official title:

Efficacy of Dexmedetomidine for the Therapy of Catheter-related Bladder Discomfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01991223
• Other study ID #: CRBD_DEX_PHPKHC
• Secondary ID: CRBD_SNUH1
• Status: Recruiting
• Phase: Phase 4
• First received: November 18, 2013
• Last updated: March 18, 2014
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2014
• Source: Seoul National University Hospital
• Contact: Hyun-Chang Kim, MD
• Email: onidori1979[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for transurethral bladder resection

• ASA I-III

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arrhythmia
• Blood Pressure
• Nausea
• Pain
• Vomiting

Intervention

Drug:
• Dex infusion
Dexmedetomidine will be injected (1 mcg/kg for 10 minutes and afterward 0.3 mcg/kg/hr)
• NS infusion
Normal saline will be infused during surgery

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University 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	The number of patients with catheter-related bladder discomfort	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.	at postoperative 1 hour	No
Secondary	Catheter-related bladder discomfort	Catheter-related bladder discomfort will be evaluated as none, mild, moderate, severe at postoperative 0, 1, 6, 24 hours.	at postoperative 0, 1, 6, 24 hours	No
Secondary	Pain at suprapubic area	Pain at suprapubic area will be evaluated using NRS (0:none, 100:worst imaginable) at postoperative 0, 1, 6, 24 hours	at postoperative 0, 1, 6, 24 hours	No