Propofol Sedation Maintained and Assisted by Patient Reaction Time
Research type
Research Study
Full title
Propofol Sedation Maintained and Assisted by Patient Reaction Time (PROSMART) A phase III multisite clinical trial in patients undergoing I. Upper GI endoscopy (Golden Jubilee National Hospital) II. Cardiac Catheterisation (Golden Jubilee National Hospital) III. Dental procedures (Forth Valley Royal Hospital)
IRAS ID
148580
Contact name
Stefan Schraag
Contact email
Sponsor organisation
NHS National Waiting Times Health Board
Duration of Study in the UK
1 years, 4 months, 3 days
Research summary
The drug propofol, the agent most commonly used to induce general anaesthesia in the UK, is also frequently given intravenously by anaesthetists in lower doses to provide sedation for patients undergoing unpleasant procedures (to become relaxed, anxiety-free, but maintain verbal contact throughout). The technique of patient maintained sedation using this drug (the patient increases the amount of sedation they receive by pressing a demand button attached to an infusion device) has been used by anaesthetists and evaluated since 1997. We incorporated an additional safety feature into the existing patient maintained sedation system, which allows the patient's reaction time to be measured and if found to be slowing to a certain extent (indicating becoming more sedated) will prevent further drug being given despite patient demand. This appears to eliminate a small risk of over sedation (previously only seen in volunteers deliberately trying to over sedate themselves) as demonstrated in a recently published pilot study. Another recently published pilot study also showed this system to be safe and effective when used in oral surgery patients. We wish to now evaluate this further in a bigger range of patient groups and larger number of patients.
REC name
West of Scotland REC 3
REC reference
15/WS/0073
Date of REC Opinion
14 Sep 2015
REC opinion
Further Information Favourable Opinion