PRIVATES
Research type
Research Study
Full title
Psychomotor Responses to Independent Visual, Auditory and Tactile Electrical stimuli during Sevoflurane sedation
IRAS ID
318168
Contact name
Christopher J Mullington
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Use of sedation, rather than general anaesthesia, has many benefits, including lower rates of postoperative confusion, shorter hospital stay and reduced environmental impact. Effective sedation is a balancing act between awareness and anaesthesia. If too little sedation is given patients may recall intraoperative events and if too much is given patients may require help with their breathing or blood pressure. Although in theory the best way to achieve this balance is to allow patients to sedate themselves by pressing a button, at present sedation is almost exclusively clinician-delivered. This is because the sedative dose at which the ability to press a button ceases is not known and thus it is not known if patients can overdose themselves. Therefore, this physiological study aims to establish the dose of sevoflurane (a commonly used sedative drug) at which healthy participants lose the ability to press a button and to find out if this occurs before their breathing or blood pressure is affected.
The study will be conducted in an operating theatre at Imperial College Healthcare NHS trust and will be funded by Intersurgical Ltd. Fifteen healthy participants will undergo the study protocol, during which increasing doses of sevoflurane will be administered through an anaesthetic facemask. At each dose participants will be asked to press a button as quickly as possible after they see a light, hear a sound, or feel a touch. Sevoflurane administration will stop when a maximum dose is reached or if the participant requires breathing or blood pressure support (whichever occurs first). The protocol duration will be approximately 6 hours.
If this study finds that the ability to press a button is lost before breathing or blood pressure is compromised, it will demonstrate the safety of patient-controlled sevoflurane sedation and could facilitate improvements in the way that sedation is delivered.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
22/WM/0227
Date of REC Opinion
8 Nov 2022
REC opinion
Further Information Favourable Opinion