Trial no.:
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PACTR202402621085427 |
Date of Approval:
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05/02/2024 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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A Comparative Evaluation Of Propofol Versus Dexmedetomidine Effects On Haemodynamic Responses, Seizure Duration And Recovery Profile Following Electroconvulsive Therapy |
Official scientific title |
A Comparative Evaluation Of Propofol Versus Dexmedetomidine Effects On Haemodynamic Responses, Seizure Duration And Recovery Profile Following Electroconvulsive Therapy |
Brief summary describing the background
and objectives of the trial
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BACKGROUND
Anaesthetists may be occasionally needed to provide anaesthesia or sedation in locations outside the operating room. These locations may include psychiatry unit for electroconvulsive therapy, endoscopy unit, radiology unit and others. The anaesthetists should always prepare for the peculiar challenges associated with nonoperating room anaesthesia.
Electroconvulsive therapy (ECT) is the induction of generalized tonic clonic seizure by application of electrical shocks of varying frequencies to one or both cerebral hemispheres through electrodes placed on the temporal area of the scalp. This is a safe and effective non-pharmacologic treatment method for many psychiatric disorders such as major depressive disorder, bipolar disorder, mania, catatonia, psychosis and others. It is also considered as the best and fastest treatment option for psychiatric disorders that are resistant to psychotherapy and pharmacotherapy.
The clinical effectiveness of propofol versus dexmedetomidine is yet to be compared among Nigerian cohorts. No literature in Nigeria, to the best of the researcher’s knowledge, has compared the effects of propofol versus dexmedetomidine on haemodynamic responses, and seizure duration and recovery profile following electroconvulsive therapy.
OBJECTIVES
1. To compare the haemodynamic changes (HR, MAP, SpO2) following the administration of propofol versus dexmedetomidine for electroconvulsive therapy.
2. To compare the duration of seizure following the use of propofol versus dexmedetomidine for electroconvulsive therapy.
3. To compare the recovery profile (time to eye opening, time to obeying command, and presence of agitation by patients) of propofol versus dexmedetomidine when used for electroconvulsive therapy anaesthesia.
4. To compare post-ECT pain using Pain Assessment in Advanced Dementia (PAINAD) scale in both groups.
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Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Anaesthesia,Mental and Behavioural Disorders |
Sub-Disease(s) or condition(s) being studied |
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Purpose of the trial |
Treatment: Drugs |
Anticipated trial start date |
18/02/2024 |
Actual trial start date |
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Anticipated date of last follow up |
30/06/2024 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
76 |
Actual target sample size (number of participants) |
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Recruitment status |
Not yet recruiting |
Publication URL |
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