Premedication With Oral Midazolam in Patients Undergoing... | NCT00563069

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

NCT00563069

Sponsor

Hospital Authority, Hong Kong

Status

Unknown status

Last Update Posted

Jul 7, 2010Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Cystoscopy

Interventions

Midazolam

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HARECCTR0500009

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Dec 2006Estimated

First Submitted Date

Nov 21, 2007

First Submission Date that Met QC Criteria

Nov 23, 2007

First Posted Date

Nov 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2010

Last Update Posted Date

Jul 7, 2010Estimated

Name	Class
Chinese University of Hong Kong	OTHER

Description Module

Brief Summary

To investigate the efficacy of oral midazolam for patients undergoing rigid cystoscopy in:

relieving patient's anxiety and improving satisfaction
reducing procedure-related pain
facilitating the diagnostic and therapeutic interventions during rigid cystoscopy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Name	Type	Description	Arm Group Labels	Other Names
Midazolam	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score during the procedure as assessed by visual analog scale

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shirley YW Liu, Dr	Contact	(852) 2632 2625		liu_yws@yahoo.com.hk

Overall Officials

Name	Affiliation	Role
Shirley YW Liu, Dr	Department of Surgery, Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery, Prince of Wales Hospital	Recruiting	Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D004194	Disease

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008874	Midazolam

Ancestor Terms

ID	Term
D001569	Benzodiazepines
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided