The effect of electroconvulsive therapy (ECT) following propofol and etomidate anaesthesia: a randomised double blind trial.

ISRCTN	ISRCTN86210347
DOI	https://doi.org/10.1186/ISRCTN86210347
Secondary identifying numbers	N0283136357

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 13/04/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Venn
Scientific

Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom

Phone	+44 (0)1903 205111 x 5151
Email	richard.venn@wash.nhs.uk

Study information

Study design	Randomised double blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	propofol and etomidate
Primary outcome measure	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 study start date	01/01/2003
Completion date	01/01/2006
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Worthing & Southlands Hospitals NHS Trust

Worthing
BN11 2DH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Sussex NHS Research Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2006		Yes	No