Condition category
Mental and Behavioural Disorders
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

  1. 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.

Additional files

Editorial Notes