Dexmedetomidine for Catheter-related Bladder Discomfort (CRBDEX)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|