derstanding CONSciousness Connectedness and Intraoperative Unresponsiveness Study-3: a randomised, double-blind, cross-over trial in healthy volunteers

Not Applicable

Recruiting

• Conditions: Sedation; Unconsciousness; Anaesthesiology - Anaesthetics; Neurological - Other neurological disorders

• Registration Number: ACTRN12623001329651
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-19
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•Adults, ages greater than or equal to 18 and 40 years old
•In good health, determined by the PI on the basis of medical history and a standard assessment for anaesthesia to be documented as part of the study record
•English Language Proficiency (suitable to provide informed consent and participate in research activities).

Exclusion Criteria

•Adults <18 years old or >40 years old
•Pregnancy confirmed on pregnancy test on day of sedation
•Use of recreational drugs
•Use of sedatives/sleeping medication within 24 hours prior to sedation visit
•Prescription for opioids (chronic or PRN) or other medications that cause sedation
•Contraindication to anaesthesia or allergy to study drug
•Difficult anaesthesia: American Society of Anesthesiologists Physical Status greater than 1, per the discretion of the PI. Examples of ASA>1 status includes, but are not limited to:
oAny systemic disease present, such as diabetes, cardiac, pulmonary, or other acute or chronic disorder, or history of smoking
oNarrow angle glaucoma
oAbnormal airway examination
oAny abnormality on physical examination that could increase anaesthetic risk
oSnoring or sleep disorders including apnea
oAntecedent pulmonary aspiration risk (e.g., history GI reflux, heartburn, hiatal hernia)
oAdverse reaction or allergy with anaesthesia or other sedatives
oChronic medication use
oHistory of difficult anaesthesia, laryngoscopy or intubation
oFamily history of difficulty with anaesthesia or sedation
oHistory of vertigo, nausea or vomiting after anaesthesia
•BMI > 35
•Contraindication to HD-EEG for relative parts of the procedures.
•Exclusion from Dexmedetomidine:
oResting heart Rate<50 bpm
oKnown dexmedetomidine allergy
•People working in anaesthesia (such as anaesthetic registrars)
•People who are occupationally exposed to the study drugs.

Additional exclusion criteria on the day of sedation:
•Anything to eat or drink for the preceding 6 hours (excluding clear fluids)
•Anything to drink for the preceding 2 hours
•Any use of over-the-counter or recreational drugs (including alcohol or tobacco) within the preceding 24 hours
•Any use of opioid, sedative or sleep agents within the preceding 24 hours
•Recent change in health, including cough, cold, or fever
•Exposure to anaesthesia or sedation in the last 6 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of conscious state between Transcranial Alternating Current Stimulation (TACS) and sham stimulation under steady state dexmedetomidine, through EEG analysis using linear mixed effect models.[ As observed during the sedation visit (8-10 hours)]