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 |
| Protocol serial number | N0283136357 |
| Sponsor | Department of Health |
| Funder | Sussex NHS Research Consortium (UK) |
- 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
Scientific
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
| Phone | +44 (0)1903 205111 x 5151 |
|---|---|
| richard.venn@wash.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | propofol and etomidate |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 |
| 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
- United Kingdom
- England
Study participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
BN11 2DH
United Kingdom
BN11 2DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
