NCT00563069

Brief Summary

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

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

First QC Date

November 21, 2007

Last Update Submit

July 6, 2010

Conditions

Cystoscopy

Keywords

diagnostic and therapeutic rigid cystoscopy

Outcome Measures

Primary Outcomes (1)

  • Pain score during the procedure as assessed by visual analog scale

Secondary Outcomes (3)

  • Patient's satisfaction

  • Patient's willingness to repeat the procedure

  • Patient's cooperativeness during the procedure as assessed by surgeons

Interventions

MidazolamDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective rigid cystoscopy
  • Either diagnostic or therapeutic
  • Age between 18 to 80

You may not qualify if:

  • Patients with allergy to midazolam or other benzodiazepine groups
  • Pregnancy
  • Emergency rigid cystoscopy
  • ASA class 3 or above
  • Patients on psychiatric medications
  • Alcoholics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Prince of Wales Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Disease

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Shirley YW Liu, Dr

    Department of Surgery, Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley YW Liu, Dr

CONTACT

(852) 2632 2625liu_yws@yahoo.com.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

September 1, 2005

Study Completion

December 1, 2006

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

CN(1)