Dexmedetomidine for Catheter-related Bladder Discomfort (CRBDEX)
|ClinicalTrials.gov Identifier: NCT01991223|
Recruitment Status : Unknown
Verified March 2014 by Hee-Pyoung Park, Seoul National University Hospital.
Recruitment status was: Recruiting
First Posted : November 25, 2013
Last Update Posted : March 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain Blood Pressure Nausea Vomiting Arrhythmia||Drug: Dex infusion Drug: NS infusion||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Efficacy of Dexmedetomidine for the Therapy of Catheter-related Bladder Discomfort|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2014|
Placebo Comparator: Placebo group
NS infusion will be done during surgery.
Drug: NS infusion
Normal saline will be infused during surgery
Experimental: Dex group
DEX infusion will be done during surgery.
Drug: Dex infusion
Dexmedetomidine will be injected (1 mcg/kg for 10 minutes and afterward 0.3 mcg/kg/hr)
- The number of patients with catheter-related bladder discomfort [ Time Frame: 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.
- Catheter-related bladder discomfort [ Time Frame: 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 [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991223
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Hee-Pyung Park, MD PhD 82-2-2072-2365 firstname.lastname@example.org|
|Principal Investigator: Hee-Pyung Park, MD PhD|
|Principal Investigator: Hyun-Chang Kim, MD|
|Principal Investigator:||Hee-Pyoung Park||Seoul National University of Hospital|