PROMPT: PROcedural sedation vs Methoxyflurane a Prospective cohorT Study.
- Conditions
- Interventional Radiology procedural analgesiaAnaesthesiology - Other anaesthesiology
- Registration Number
- ACTRN12623001127695
- Lead Sponsor
- South Western Sydney Local Health District Human Research Ethics Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 150
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
pregnancy
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The efficacy and safety of methoxyflurane use in interventional radiology procedures using using Clavien Dindo classification.[ Before patient is discharged from the department (upto ~3hours after the procedure).];Pain levels assessed using visual-analogue scale (VAS)<br>[ Baseline score before procedure (~30min)<br>at set intervals during the procedure (every 10mins for the duration of the procedure)<br>Before patient is discharged from the department (~1hour after the procedure).<br>];Anxiety assessed using Generalized Anxiety Disorder 2 (GAD-2).[ Baseline score before procedure (~30min)<br>at set intervals during the procedure (every 10mins for the duration of the procedure)<br>Before patient is discharged from the department (~1hour after the procedure).]
- Secondary Outcome Measures
Name Time Method A study-specific survey has post procedure questionnaires will include assessment of patient experience, willingness to undergo the procedure again with this form of analgesia or sedation, and satisfaction with care.[ Before patient is discharged from the department; This will be done in roughly 30-60mins after the procedure.];Procedure duration is recored using medical recores as per the standard of care for all procedures performed; this will be used to complete data collection.[ This will be calculated based on the duration of the proccedure at the end of the proccedure.]