Dexmedetomidine for Catheter-related Bladder Discomfort

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

Sponsors

Lead Sponsor: Seoul National University Hospital

Source 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

Overall Status Unknown status
Start Date November 2013
Completion Date November 2014
Primary Completion Date November 2014
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
The number of patients with catheter-related bladder discomfort at postoperative 1 hour
Secondary Outcome
Measure Time Frame
Catheter-related bladder discomfort at postoperative 0, 1, 6, 24 hours
Pain at suprapubic area at postoperative 0, 1, 6, 24 hours
Enrollment 114
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dex infusion

Description: Dexmedetomidine will be injected (1 mcg/kg for 10 minutes and afterward 0.3 mcg/kg/hr)

Arm Group Label: Dex group

Intervention Type: Drug

Intervention Name: NS infusion

Description: Normal saline will be infused during surgery

Arm Group Label: Placebo group

Eligibility

Criteria:

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

Gender: All

Minimum Age: 19 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Hee-Pyoung Park Principal Investigator Seoul National University of Hospital
Overall Contact

Last Name: Hyun-Chang Kim, MD

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Seoul National University Hospital Hee-Pyung Park, MD PhD 82-2-2072-2365 [email protected] Hee-Pyung Park, MD PhD Principal Investigator Hyun-Chang Kim, MD Principal Investigator
Location Countries

Korea, Republic of

Verification Date

March 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University Hospital

Investigator Full Name: Hee-Pyoung Park

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo group

Type: Placebo Comparator

Description: NS infusion will be done during surgery.

Label: Dex group

Type: Experimental

Description: DEX infusion will be done during surgery.

Acronym CRBDEX
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov