HAREC Clinical Trial Registry Record
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Title for Public Premedication with oral midazolam in patients undergoing rigid cystoscopy: A randomized, double-blind, placebo-controlled trial
HAREC ID HARECCTR0500009
Scientific Title Premedication with oral midazolam in patients undergoing rigid cystoscopy: A randomized, double-blind, placebo-controlled trial

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

Trial ID
HA REC Trial ID CRE-2005.250-T
Name of CREC Joint CUHK-NTEC CREC

Other Trial IDs

Lead Principal Investigator
Name Dr   Shirley Yuk Wah   Liu
Department/Unit Surgery
Institute/Hospital Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong

Contact person
Name Dr   Shirley Yuk Wah   Liu
Department/Unit Surgery
Institute/Hospital Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong
Phone 26322625
Fax 26377974
Internet Mail liu_yws@yahoo.com.hk

Disease/s or Condition/s
diagnostic and therapeutic rigid cystoscopy

Intervention/s
Intervention 1
Intervention Name Midazolam
Type of Intervention Drug
Duration 1 Day
Other details single dose
Active Control YES

Inclusion and Exclusion Criteria
Gender Non-specific
Age 18-80
Inclusion and Exclusion Criteria Inclusion criteria
i. Elective rigid cystoscopy
ii. Either diagnostic or therapeutic
iii. Age between 18 to 80

Exclusion criteria
i. Patients with allergy to midazolam or other benzodiazepine groups
ii. Pregnancy
iii. Emergency rigid cystoscopy
iv. ASA class 3 or above
v. Patients on psychiatric medications
vi. Alcoholics

Study Type Interventional
Purpose Prevention
Allocation Randomized controlled trial
Masking Double blind
Control Placebo
Assignment Single group
Endpoint Efficacy

Primary Outcome/s
Outcome name Pain score during the procedure as assessed by visual analog scale
Timepoint

Secondary Outcome/s
Outcome name Patient's satisfaction
Timepoint
Outcome name Patient's willingness to repeat the procedure
Timepoint
Outcome name Patient's cooperativeness during the procedure as assessed by surgeons
Timepoint

Date of First Enrollment 2005-09-17
(yyyy-mm-dd)

Target Sample Size 120

Recruitment Status Recruiting

Funding Source/s

Primary Sponsor
Name The Chinese University of Hong Kong
Address or contact information

Secondary Sponsor

Research Ethics Board/Committee Approval YES

Co-Investigator/s
Name Dr Wilfred Lik Man Mui
Department SUR
Organization Prince of Wales Hospital/ The Chinese University of Hong Kong

Name Dr Chi Fai Ng
Department SUR
Organization Prince of Wales Hospital/ The Chinese University of Hong Kong

Name Dr Michael Chi Wai Cheng
Department SUR
Organization Prince of Wales Hospital/ The Chinese University of Hong Kong

Name Dr Shu Yin Chan
Department SUR
Organization Prince of Wales Hospital/ The Chinese University of Hong Kong


Study Site/s
Local site/s Department Organization
1 SUR Prince of Wales Hospital

Clinical Specialty Surgery

Proposed Date of Last Follow-up 2006-12-30
(yyyy-mm-dd)

Registration Date 2005-09-10
(yyyy-mm-dd)

Submission Date 2005-09-09
(yyyy-mm-dd)

Record Status Verified; registration accepted - complete data. October 2005