None listed
Conditions
Brief summary
Trial to explore depth of anaesthetic and quality of recovery through randomising patients to a low or standard bispectral index (measurement in theatres to determine how "deeply" unconscious a patient it using EEG electrodes). Patients will be followed up for quality of recovery pain, nausea and vomiting as well as post-anaesthetic surveys at 24 hours and 7 days. Additionally, blood samples will be collected and analysed for hormone levels.
Interventions
Randomisation to a bispectral index of 45-50 intraoperatively or 30-35 for the total length of surgery beginning from after induction. Length of surgery time will vary based on operation type and patient differences. Bispetral index will be measured on the in-theatre BIS machine which is purpose built for this observation. The anaesthetic technique during induction is protocolised to include - midazolam, remifentanil and propofol based on the schnieder and minto models. Anaesthetics doctors are
Randomisation to a bispectral index of 45-50 intraoperatively or 30-35 for the total length of surgery beginning from after induction. Length of surgery time will vary based on operation type and patient differences. Bispetral index will be measured on the in-theatre BIS machine which is purpose built for this observation. The anaesthetic technique during induction is protocolised to include - midazolam, remifentanil and propofol based on the schnieder and minto models. Anaesthetics doctors are assessed for adherence to BIS using a 0-10 confidence rating scale (self-reported to research staff).
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
• Adults undergoing non-emergency general anaesthesia • Sex: Female • Age range: 18-40 years old • ASA 1, 2, or 3 • Willingness to provide informed consent and willingness to participate and comply with the study requirements
Exclusion criteria
• Pregnant women • Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements. • Participants with cognitive impairment that is likely to interfere with the evaluation of the participant’s safety and of the study outcome. • Participants requiring rapid sequence induction during induction of general anaesthesia • Previous severe adverse reaction to midazolam, remifentanil and/or propofol • For the Induction Phase Study - Body mass index (BMI) > 35kg/m2 (limit of Schnider Propofol TCI model)
Outcome results
None listed