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

July 6, 2010 updated by: Hospital Authority, Hong Kong

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain score during the procedure as assessed by visual analog scale

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Anticipated)

December 1, 2006

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 23, 2007

First Posted (Estimate)

November 26, 2007

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2005.250-T
  • HARECCTR0500009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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