Not Yet RecruitingPhase 3Phase 4ACTRN12610000499088

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).


Sponsor

Michael Keane

Enrollment

45 participants

Start Date

Jun 30, 2010

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a sedation medication called dexmedetomidine can improve comfort during common urological and gynecological procedures like cystoscopy, hysteroscopy, or prostate biopsy. It is for adults aged 18 and over scheduled for one of these procedures. People with severe health conditions, very low heart rate, low blood pressure, or those needing spinal anesthesia are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 intraveno

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)

Australia

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ACTRN12610000499088