Contact information
Type
Scientific
Primary contact
Dr Richard Venn
ORCID ID
Contact details
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
+44 (0)1903 205111 x 5151
richard.venn@wash.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0283136357
Study information
Scientific title
Acronym
Study hypothesis
1. To investigate whether an increased stimulus dose is required to produce a tonic/clonic convulsion duration of greater than or equal to 15 s when propofol is used as an alternative to etomidate for anaesthesia during electroconvulsive therapy (ECT).
2. To investigate whether the incidence of cognitive side-effects is influenced independently by the anaesthetic agents propofol and etomidate, or as a consequence of differences in stimulus dose required for ECT. (Cognitive side effects to be measured by Folstein Mini-Mental State Examination [FMM], Paired Associate Learning Test [PALT], and subjective rating of memory).
Ethics approval
Not provided at time of registration
Study design
Randomised double blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Mental and Behavioural Disorders: Electroconvulsive therapy (ECT)
Intervention
1. Etomidate (smallest amount of induction agent to achieve loss of consciousness)
2. Propofol (smallest amount of induction agent to achieve loss of consciousness)
Added 21 July 2008: the trial was discontinued in 2006 due to poor recruitment.
Intervention type
Drug
Phase
Not Specified
Drug names
propofol and etomidate
Primary outcome measures
Evaluation of depression by Beck Depression Inventory and Clinician's Global Impression of Change, number of ECT sessions, duration of motor and EEG seizure, evaluation of cognitive side effects by Folstein Mini-Mental State Examination, Paired Associate Learning Test and subjective rating of memory.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
01/01/2006
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Patients, over 18 years old, with a major depressive illness who are to receive electroconvulsive therapy (ECT), and who have given written informed consent for the study.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
01/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Sussex NHS Research Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16957533
Publication citations
-
Results
Patel AS, Gorst-Unsworth C, Venn RM, Kelley K, Jacob Y, Anesthesia and electroconvulsive therapy: a retrospective study comparing etomidate and propofol., J ECT, 2006, 22, 3, 179-183, doi: 10.1097/01.yct.0000230362.96615.d9.