CystoscopyNCT00563069
Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial
A study testing Midazolam in people with Cystoscopy, run by Hospital Authority, Hong Kong at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cystoscopy
- What is being tested?
- Midazolam
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2005to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Elective rigid cystoscopy
- Either diagnostic or therapeutic
- Age between 18 to 80
Who cannot join
- Patients with allergy to midazolam or other benzodiazepine groups
- Pregnancy
- Emergency rigid cystoscopy
- ASA class 3 or above
- Patients on psychiatric medications
- Alcoholics
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Surgery, Prince of Wales Hospital
Hong Kong
Wilfred LM Mui, Dr
Chi Fai Ng, Dr
About this study
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
- Conditions
- Cystoscopy
- Being tested
- Midazolam
- Keywords
- diagnostic and therapeutic rigid cystoscopy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startSep 2005
- Study completionDec 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Chinese University of Hong Kong
- Investigators
- Shirley YW Liu, Dr, Principal investigator, Department of Surgery, Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563069
- Sponsor's protocol ID
- CRE-2005.250-T
- Other IDs
- HARECCTR0500009
- Status last verified
- Jul 2010
- First submitted
- 21 Nov 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication With Oral Midazolam in Patients Undergoing Rigid Cystoscopy: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT00563069
- Acronym / sponsor ID
- CRE-2005.250-T
- Conditions
- Cystoscopy
- Keywords
- diagnostic and therapeutic rigid cystoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Chinese University of Hong Kong
- Study start
- Sep 2005
- Study completion
- Dec 2006 (estimated)
- First posted
- 26 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective rigid cystoscopy
- Either diagnostic or therapeutic
- Age between 18 to 80
Key exclusion criteria (6 listed)
- Patients with allergy to midazolam or other benzodiazepine groups
- Pregnancy
- Emergency rigid cystoscopy
- ASA class 3 or above
- Patients on psychiatric medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam | Drug | – |
Primary outcome
Pain score during the procedure as assessed by visual analog scale
3 secondary outcomes
Patient's satisfaction
Patient's willingness to repeat the procedure
Patient's cooperativeness during the procedure as assessed by surgeons
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
Related trials for Cystoscopy
RecruitingPhase 3
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Bladder Cancer
RecruitingObservational study
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
Genitourinary Anatomy
RecruitingObservational study
Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Bladder Cancer, Non-muscle Invasive Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Recruiting
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
Benign Prostatic Hyperplasia (BPH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shirley YW Liu, Dr principal investigator
Department of Surgery, Prince of Wales Hospital/ The Chinese Univerisity of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam in people with Cystoscopy, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley YW Liu, Dr ((852) 2632 2625, liu_yws@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score during the procedure as assessed by visual analog scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.