Bispectral Index monitoring for intravenous sedation in dentistry
Research type
Research Study
Full title
An investigation of the use of Bispectral index monitoring when providing intravenous conscious sedation for adults who have a severe cognitive disability
IRAS ID
293705
Contact name
Mili Doshi
Contact email
Sponsor organisation
The Royal Hospital for Neuro-disability Head of research
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
The title of the study - An investigation of the use of Bispectral index monitoring when providing intravenous conscious sedation for adults who have a severe cognitive disability
The use of intravenous conscious sedation in dentistry for people with a cognitive disability has been established. Conscious sedation requires continuing verbal contact and response from the patient. Assessment by the dental surgeon of the level of sedation throughout treatment is judged by objective (oxygen saturation, heart rate with pulse oximetry) and subjective (response to treatment, verbal communication) methods. For adults with disability, verbal communication may not be possible. The bispectral (BIS) index monitor measures brain activity and is a representation of the level of consciousness. This, therefore, provides an objective aid to assessing consciousness in individuals with limited verbal communication.Background - The BIS monitor has been shown to be of value for the dental treatment of anxious adults but has not yet been evaluated for those with a cognitive disability. For patients with non-verbal communication, the use of the BIS monitor may enhance the safety of sedation. In addition, BIS monitoring may help support the subjective assessments of consciousness levels for dental surgeons new to sedation.
The study will be conducted in three centres The Royal Hospital for Neurodisability, East Surrey Hospital and Canterbury Health Centre. Eligible participants will be those who present with non-verbal means of communication who require dental treatment under conscious sedation. Sedation and treatment will be conducted by clinicians who are specialists in Special Care Dentistry and experienced in the treatment of adults with disability. The researcher will evaluate whether using a BIS monitor is feasible for this patient cohort when providing dental care under sedation. The only variation in the standard clinical process will be applying BIS sensor pads for monitoring the patient.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0041
Date of REC Opinion
24 Mar 2022
REC opinion
Further Information Favourable Opinion