None listed
Conditions
Brief summary
ConsCIOUS-3 is a single site, randomised control trial, using the trial drug dexmedetomidine or placebo given during general anaesthetic induction. The primary objective of this study is to determine whether a commonly used anaesthetic drug and sedative, dexmedetomidine, may reduce rises in the Bispectral Index. Healthy participants, aged 18-40, will be recruited from surgical lists and enrolled prior to surgery. Data collection will occur intra-operatively, post-operatively in recovery and at 24-hours and 7-days post-operation.
Interventions
Dexmedetomidine 0.5mg/kg will be given intravenously (IV) over 5 minutes prior to/during intubation during a general anaesthetic.
This will be administered by the treating anaestheist and will be monitored by the principal investigator Professor Robert Sanders. Anaesthetic doctors will be trained on study protocol prior to comencement of the trial and will record the drug administration in the anaesthetic chart as dexmedetomidine/placebo. If there are any errors in administration or dose this wi
Dexmedetomidine 0.5mg/kg will be given intravenously (IV) over 5 minutes prior to/during intubation during a general anaesthetic. This will be administered by the treating anaestheist and will be monitored by the principal investigator Professor Robert Sanders. Anaesthetic doctors will be trained on study protocol prior to comencement of the trial and will record the drug administration in the anaesthetic chart as dexmedetomidine/placebo. If there are any errors in administration or dose this will be reported to Professor Robert Sanders and the Research Coordinator and documented/reported as required by the local HREC.
Sponsors
Royal Prince Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Adults, 18 -40 years old requiring intubation for general anaesthesia American Society of Anaesthesiologists status (ASA) 1, 2 or 3 Able and willing to provide informed consent, participate and comply with study requirements Support of treating surgical team for participant invovlement
Exclusion criteria
Persons who are lactating or pregnant Persons with a history of allergy to dexmedetomidine Persons with history of heart block Persons with a history of psychological illness or other conditions with may interfere with their ability to understand the study requirements Persons with cognitive impairment that is likely to interfere with the evaluation of participant's safety and of the study outcome
Outcome results
None listed