Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000499088
Ethics application status
Approved
Date submitted
2/06/2010
Date registered
17/06/2010
Date last updated
17/06/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of the use of dexmedetomidine for cystoscopy, hysteroscopy and transrectal ultrasound guided biopsy of the prostate (TRUS biopsy)
Scientific title
Study of the tolerability and effectiveness for surgeons and patients of the use of dexmedetomidine for cystoscopy, hysteroscopy and transrectal ultrasound guided biopsy of the prostate (TRUS biopsy).
Secondary ID [1] 251921 0
nil
Universal Trial Number (UTN)
U1111-1115-4312
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaesthesia for cystoscopy, hysteroscopy and TRUS biopsy 257504 0
Condition category
Condition code
Anaesthesiology 257661 257661 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who require cystoscopy, hysteroscopy or TRUS biopsy will be given an anaesthetic regimen based on dexmedetomidine. The procedures will be a one off.

Dexmedetomidine will be given intravenously (IV). Patients will receive a loading dose of 1 microgram per kilogram over 10 minutes. The design of the study incorporates the potential for this loading dose to increase or decrease as data about the response from patients is included.

After the loading dose, patients will be maintained on an infusion that will be adjusted according to response from between 0.2 micrograms / kilogram / hour and 1.4 micrograms / kilogram /hour.

The infusion will be maintained for the duration of the procedure. The procedures are expected to last for less than 30 minutes.
Intervention code [1] 256597 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258568 0
Acceptability to surgeons. Dichotomous question of whether the operating conditions were acceptable or not in regards to performing the procedure to an acceptable standard of care.
Timepoint [1] 258568 0
during surgery
Primary outcome [2] 258572 0
Patient satisfaction. 10 cm Visual Analogue Scale (VAS). Patients will be asked how satisfied they were with the regimen they received for sedation/anaesthesia. The VAS will be from 0 (very unsatisfied) to 10 (very satisfied).
Timepoint [2] 258572 0
post operation
Primary outcome [3] 258573 0
the number of times the anaesthetist has to intervene to support the patient's airway or breathing and what the intervention consisted of
Timepoint [3] 258573 0
during sugery
Secondary outcome [1] 264435 0
Dose of dexmedetomidine used
Timepoint [1] 264435 0
during surgery

Eligibility
Key inclusion criteria
patients scheduled for cystoscopy, hysteroscopy and TRUS biopsy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
American Society of Anesthesiologists (ASA) score of IV;

patients who require an epidural or spinal anesthesia;

acute unstable angina or acute myocardial infarction in the past 6 week;

heart rate less than 50;

systolic blood pressure less than 90 mm Hg;

third-degree heart block unless the patient has a pacemaker

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257095 0
Hospital
Name [1] 257095 0
Casey Hospital
Country [1] 257095 0
Australia
Primary sponsor type
Individual
Name
Michael Keane
Address
c/- Dept Anaesthetics
Casey Hospital
52 Kangan Drive
Berwick
Victoria
3806
Country
Australia
Secondary sponsor category [1] 256352 0
None
Name [1] 256352 0
Address [1] 256352 0
Country [1] 256352 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Hysteroscopies and cystoscopies are typically done under general anaesthesia in our hospital network. TRUS biopsies are typically done under deep sedation. While these methods are considered very safe as practised in Australia, they still carry risks (including obstruction of the airway and cessation of breathing.)

Dexmedetomidine is a sedative agent that is considered stable as far as the airway and breathing is concerned. This study will assess whether these procedures can successfully be performed using a regimen based on dexmedetomidine.

When having a general anaesthetic, patients require an artificial tube to be placed into the back of their throat or windpipe. When using a regimen based on dexmedetomidine, it is predicted that patients will not need that tube, and will be able to breath without it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31249 0
Address 31249 0
Country 31249 0
Phone 31249 0
Fax 31249 0
Email 31249 0
Contact person for public queries
Name 14496 0
Michael Keane
Address 14496 0
c/- Anaesthetic Dept
Casey Hospital
52 Kangan Drive
Berwick
Victoria 3806
Country 14496 0
Australia
Phone 14496 0
+61 3 8768 1772
Fax 14496 0
Email 14496 0
mikekeane00@hotmail.com
Contact person for scientific queries
Name 5424 0
Michael Keane
Address 5424 0
c/- Anaesthetic Dept
Casey Hospital
52 Kangan Drive
Berwick
Victoria
3806
Country 5424 0
Australia
Phone 5424 0
+61 3 8768 1772
Fax 5424 0
Email 5424 0
mikekeane00@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIObservational Study of Dexmedetomidine for Hysteroscopy, Cystoscopy and Transrectal Ultrasound Biopsy2014https://doi.org/10.1177/0310057x1404200106
N.B. These documents automatically identified may not have been verified by the study sponsor.