AnaeWARE: A study on how anesthetics affect the human body
Research type
Research Study
Full title
AnaeWARE: Combining standard monitoring parameters and electrical brain activity into a multimodal index for monitoring awareness during surgery
IRAS ID
146445
Contact name
Ruth Nicholson
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
A reliable assessment of anesthetic level remains a non-trivial task for the anesthetist. The study focuses on identifying reliable parameters for monitoring anesthetic depth. In particular, we will investigate: (1) how anesthetics change the relationships between different signals monitored during surgery; and (2) which changes in these relationships give reliable information about how well anesthetized a patient is. This information will be incorporated into a (multimodal) index of anesthetic depth, with the long-term goal of using this index in devices for monitoring patients during surgery. A secondary aim of the study is to investigate whether we can also use this index to predict when a patient is going to wake up during the surgery, which has not been achieved by any existing device so far, and prompt the anesthetist for action. For this we will use models of how anesthetics affect the body and investigate if there are changes in any model parameters that precede the switch from wakefulness to anesthesia (and vice versa). For the purposes of the study we aim to recruit 70-100 eligible adult patients scheduled for elective surgery at Hammersmith Hospital, London. Taking part will consist of: (1) allowing us to record anonymous routinely monitored data, e.g. heart rate, and electrical brain activity (electroencephalogram, EEG) during surgery; and (2) completing anonymous pre- and post-surgical questionnaires. All collected data will be stored in an anonymous database and analysed offline to develop an index of anesthetic depth. EEG recording will be done using a standard medical EEG system; this does not pose any additional risk to the participant. The recruitment of surgical patients is integral to the study: the development of indices of anesthetic depth should be based on data obtained during actual surgery. Only then the findings will be reliable, realistic and reflect true surgical conditions.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
15/WM/0026
Date of REC Opinion
21 Jan 2015
REC opinion
Favourable Opinion