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Dexmedetomidine for Catheter-related Bladder Discomfort (CRBDEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort

Condition or disease Intervention/treatment Phase
Pain Blood Pressure Nausea Vomiting Arrhythmia Drug: Dex infusion Drug: NS infusion Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

Eligibility Criteria

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for transurethral bladder resection

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
Contacts and Locations

Information from the National Library of Medicine

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

Contact: Hyun-Chang Kim, MD onidori1979@gmail.com
Contact: Hee-Pyong Park, Ph.D hppark@snu.ac.kr

Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hee-Pyung Park, MD PhD    82-2-2072-2365    hppark@snu.ac.kr   
Principal Investigator: Hee-Pyung Park, MD PhD         
Principal Investigator: Hyun-Chang Kim, MD         
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Hee-Pyoung Park Seoul National University of Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hee-Pyoung Park, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01991223     History of Changes
Other Study ID Numbers: CRBD_DEX_PHPKHC
CRBD_SNUH1 ( Other Grant/Funding Number: Seoul National University of Hospital )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action