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Dexmedetomidine for Catheter-related Bladder Discomfort (CRBDEX)

Primary Purpose

Pain, Blood Pressure, Nausea

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dex infusion
NS infusion
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

Dex group

Arm Description

NS infusion will be done during surgery.

DEX infusion will be done during surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Catheter-related bladder discomfort
Catheter-related bladder discomfort will be evaluated as none, mild, moderate, severe at postoperative 0, 1, 6, 24 hours.
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

Full Information

First Posted
November 18, 2013
Last Updated
March 18, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01991223
Brief Title
Dexmedetomidine for Catheter-related Bladder Discomfort
Acronym
CRBDEX
Official Title
Efficacy of Dexmedetomidine for the Therapy of Catheter-related Bladder Discomfort
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Blood Pressure, Nausea, Vomiting, Arrhythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
NS infusion will be done during surgery.
Arm Title
Dex group
Arm Type
Experimental
Arm Description
DEX infusion will be done during surgery.
Intervention Type
Drug
Intervention Name(s)
Dex infusion
Intervention Description
Dexmedetomidine will be injected (1 mcg/kg for 10 minutes and afterward 0.3 mcg/kg/hr)
Intervention Type
Drug
Intervention Name(s)
NS infusion
Intervention Description
Normal saline will be infused during surgery
Primary Outcome Measure Information:
Title
The number of patients with catheter-related bladder discomfort
Description
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.
Time Frame
at postoperative 1 hour
Secondary Outcome Measure Information:
Title
Catheter-related bladder discomfort
Description
Catheter-related bladder discomfort will be evaluated as none, mild, moderate, severe at postoperative 0, 1, 6, 24 hours.
Time Frame
at postoperative 0, 1, 6, 24 hours
Title
Pain at suprapubic area
Description
Pain at suprapubic area will be evaluated using NRS (0:none, 100:worst imaginable) at postoperative 0, 1, 6, 24 hours
Time Frame
at postoperative 0, 1, 6, 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun-Chang Kim, MD
Email
onidori1979@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-Pyong Park, Ph.D
Email
hppark@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee-Pyoung Park
Organizational Affiliation
Seoul National University of Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee-Pyung Park, MD PhD
Phone
82-2-2072-2365
Email
hppark@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Hee-Pyung Park, MD PhD
First Name & Middle Initial & Last Name & Degree
Hyun-Chang Kim, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
25485879
Citation
Kim HC, Lee YH, Jeon YT, Hwang JW, Lim YJ, Park JE, Park HP. The effect of intraoperative dexmedetomidine on postoperative catheter-related bladder discomfort in patients undergoing transurethral bladder tumour resection: A double-blind randomised study. Eur J Anaesthesiol. 2015 Sep;32(9):596-601. doi: 10.1097/EJA.0000000000000196.
Results Reference
derived

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Dexmedetomidine for Catheter-related Bladder Discomfort

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