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

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ClinicalTrials.gov Identifier: NCT00563069
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : July 7, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Cystoscopy Drug: Midazolam

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial
Study Start Date : September 2005
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Pain score during the procedure as assessed by visual analog scale

Secondary Outcome Measures :
  1. Patient's satisfaction
  2. Patient's willingness to repeat the procedure
  3. Patient's cooperativeness during the procedure as assessed by surgeons

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00563069     History of Changes
Other Study ID Numbers: CRE-2005.250-T
HARECCTR0500009
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

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

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