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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563069
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
History of Changes
  Purpose

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

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

Condition Intervention
Cystoscopy
 Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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

ClinicalTrials.gov Identifier: NCT00563069     History of Changes
Other Study ID Numbers: CRE-2005.250-T, HARECCTR0500009
Study First Received: November 21, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:
diagnostic and therapeutic rigid cystoscopy

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013