Study of the use of dexmedetomidine for cystoscopy, hysteroscopy and transrectal ultrasound guided biopsy of the prostate (TRUS biopsy)

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).

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000499088

Enrollment

Registered

2010-06-17

Start date

2010-06-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

patients scheduled for cystoscopy, hysteroscopy and TRUS biopsy

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

Outcome results