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).
Michael Keane
45 participants
Jun 30, 2010
Interventional
Conditions
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.
Eligibility
Plain Language Summary
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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.
Locations(1)
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ACTRN12610000499088