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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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
Chinese University of Hong Kong
Information provided by:
Hospital Authority, Hong Kong Identifier:
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010

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
Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
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:

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00563069

Contact: Shirley YW Liu, Dr (852) 2632 2625

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
Principal Investigator: Shirley YW Liu, Dr Department of Surgery, Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong
  More Information

Additional Information: Identifier: NCT00563069     History of Changes
Other Study ID Numbers: CRE-2005.250-T
Study First Received: November 21, 2007
Last Updated: July 6, 2010

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

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017