Prospective randomised double arm study comparing safety, pain and anxiety outcomes between methoxyflurane vs intravenous fentanyl and midazolam for patients requiring interventional radiological procedures

South Western Sydney Local Health District Human Research Ethics Committee0 个研究点目标入组 150 人开始时间: 2023年11月1日最近更新: 2023年11月6日

适应症

试验速览

暂无简介。

•Patients requiring periprocedural analgesia or sedation above local anaesthesia alone for procedures in the Liverpool Hospital Interventional Radiology Department will be offered participation in the study. Participants must be over 18 years of age and have capacity to provide consent. Written informed voluntary consent will be obtained. Patients must be hemodynamically stable. Expected procedure time must be under 2 hours.
•able to consent for procedure and participation in research
•patients requiring periprocedural analgesia or sedation above local anaesthesia alone
•hemodynamically stable
•expected procedure time <2h
•over 18 years of age

•The research project will be discussed with the patients at the time of consent. It will be clearly explained that they may opt out of the study or deny/withdraw consent at any stage. Patients unable to provide informed, voluntary, competent consent will be excluded. Similarly, if a sufficient understanding or communication cannot be established, including NESB/CALD, the patient will need to be excluded from the study and included in the discussion/exclusions analysis.
•Any patient with allergy or prior adverse reaction to methoxyflurane, midazolam or fentanyl will be excluded from the study. Patients requiring general anaesthesia or formal support by anaesthetist (e.g. needing intubation) will also be excluded.
•Patients with impaired renal function (eGFR<50) or liver dysfunction will be excluded due to the random possibility of receiving methoxyflurane as per standard of care for the safe administration of methoxyflurane based on the Australia Medical Handbook, Liverpool Hospital protocol and the Australian Therapeutic Goods Administration.
•renal impairment (eGFR<50)
•liver dysfunction
•opt out or refusal
•requiring general anaesthesia or formal support by anaesthetist (e.g. needing intubation)
•prior allergy or adverse reaction to methoxyflurane, midazolam or fentanyl

发起方

South Western Sydney Local Health District Human Research Ethics Committee