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NCT00563069 Clinical Trial

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

Cystoscopy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00563069
Other study ID # CRE-2005.250-T
Secondary ID HARECCTR0500009
Status Recruiting
Phase N/A
First received November 21, 2007
Last updated July 6, 2010
Start date September 2005
Est. completion date December 2006

Study information
Verified date July 2010
Source Hospital Authority, Hong Kong
Contact Shirley YW Liu, Dr
Phone (852) 2632 2625
Email liu_yws@yahoo.com.hk
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Midazolam

Locations
Country Name City State
China Department of Surgery, Prince of Wales Hospital Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain score during the procedure as assessed by visual analog scale
Secondary Patient's satisfaction
Secondary Patient's willingness to repeat the procedure
Secondary Patient's cooperativeness during the procedure as assessed by surgeons
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