Dexmedetomidine for Catheter-related Bladder Discomfort

NCT ID: NCT01991223

Last Updated: 2014-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-11-30

Brief Summary

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To evaluate the efficacy of dexmedetomidine for the prevention of catheter-related bladder discomfort

Detailed Description

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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

Conditions

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Pain Blood Pressure Nausea Vomiting Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo group

NS infusion will be done during surgery.

Group Type PLACEBO_COMPARATOR

NS infusion

Intervention Type DRUG

Normal saline will be infused during surgery

Dex group

DEX infusion will be done during surgery.

Group Type EXPERIMENTAL

Dex infusion

Intervention Type DRUG

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

Interventions

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Dex infusion

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

Intervention Type DRUG

NS infusion

Normal saline will be infused during surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee-Pyoung Park

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hee-Pyoung Park

Role: PRINCIPAL_INVESTIGATOR

Seoul National University of Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun-Chang Kim, MD

Role: CONTACT

Hee-Pyong Park, Ph.D

Role: CONTACT

Facility Contacts

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Hee-Pyung Park, MD PhD

Role: primary

82-2-2072-2365

References

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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.

Reference Type DERIVED
PMID: 25485879 (View on PubMed)

Other Identifiers

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CRBD_SNUH1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CRBD_DEX_PHPKHC

Identifier Type: -

Identifier Source: org_study_id

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