Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-Blind, Placebo-Controlled Trial

This study is currently recruiting participants.

Verified by Hospital Authority, Hong Kong, June 2008

First Received: November 21, 2007 Last Updated: December 15, 2008 History of Changes

Sponsors and Collaborators:	Hospital Authority, Hong Kong Chinese University of Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00563069

Purpose

To investigate the efficacy of oral midazolam for patients undergoing rigid cystoscopy in:

relieving patient's anxiety and improving satisfaction
reducing procedure-related pain
facilitating the diagnostic and therapeutic interventions during rigid cystoscopy

Condition	Intervention
Cystoscopy	Drug: Midazolam

MedlinePlus related topics: Surgery

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-Blind, Placebo-Controlled Trial

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

Pain score during the procedure as assessed by visual analog scale

Secondary Outcome Measures:

Patient's satisfaction
Patient's willingness to repeat the procedure
Patient's cooperativeness during the procedure as assessed by surgeons

Estimated Enrollment:	120
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Elective rigid cystoscopy
Either diagnostic or therapeutic
Age between 18 to 80

Exclusion Criteria:

Patients with allergy to midazolam or other benzodiazepine groups
Pregnancy
Emergency rigid cystoscopy
ASA class 3 or above
Patients on psychiatric medications
Alcoholics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563069

Contacts

Contact: Shirley YW Liu, Dr

(852) 2632 2625

liu_yws@yahoo.com.hk

Locations

China
Department of Surgery, Prince of Wales Hospital	Recruiting
Hong Kong, China
Sub-Investigator: Wilfred LM Mui, Dr
Sub-Investigator: Chi Fai Ng, Dr
Sub-Investigator: Michael CW Cheng, Dr
Sub-Investigator: Shu Yin Chan, Dr

Sponsors and Collaborators

Hospital Authority, Hong Kong

Chinese University of Hong Kong

Investigators

Principal Investigator:

Shirley YW Liu, Dr

Department of Surgery, Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong

More Information

Additional Information:

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CRE-2005.250-T, HARECCTR0500009
Study First Received:	November 21, 2007
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00563069 History of Changes
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

diagnostic and therapeutic rigid cystoscopy

Study placed in the following topic categories:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Anesthetics, General
Hypnotics and Sedatives
Psychotropic Drugs

Adjuvants, Immunologic
Central Nervous System Depressants
Anesthetics
Muscle Rigidity
Anti-Anxiety Agents
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants

Midazolam
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009