RecruitingPhase 4NCT04828226

Clonidine to Prevent Delirium After Electroconvulsive Therapy.

Clonidine to Prevent Postictal Delirium After ElectroConvulsive Therapy: a Randomised, Placebo-controlled, Triple-blind, Single-centre Trial.


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

130 participants

Start Date

Apr 27, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Electroconvulsive therapy (ECT) is a highly effective treatment for some psychiatric disorders like major depressive or bipolar disorder, but may lead to agitation and delirium after the procedure in up to 65% of patients. This can have negative side effects and be dangerous for patient and attending staff. Clonidine, a central-acting alpha2-receptor agonist, is an approved antihypertensive medication with known sedative side effects. Clonidine's newer but more expensive successor, dexmedetomidine, has recently shown its potential to reduce this kind of delirium. The investigators therefore hypothesise that pre-treatment with 2 mcg/kg clonidine prior to electroconvulsive therapy will significantly reduce the incidence of postictal delirium. This potentially makes a highly efficient treatment for patients with otherwise refractory psychiatric illness safer and more accessible.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a drug called clonidine, given before an electroconvulsive therapy (ECT) session, can prevent confusion and delirium — a sudden state of mental disorientation — that sometimes occurs after ECT. ECT is an effective treatment for severe depression, but temporary confusion is a common side effect. **You may be eligible if...** - You are 18 years or older - You are scheduled for a planned (non-emergency) series of ECT sessions at the University Hospital Bern - You are able to give informed consent yourself **You may NOT be eligible if...** - You have low blood pressure, slow heart rate, or a heart conduction problem (AV block) - You are already taking clonidine for another reason (e.g., high blood pressure) - Your ECT session is an emergency - You are unable to give consent due to mental incapacity - You have participated in another drug study in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClonidine

Clonidine 2mcg/kg Body Weight diluted in 100ml sodium chloride 0.9% compared to placebo (sodium chloride 0.9% alone) given over 10 minutes, 10 minutes prior to electroconvulsive therapy.

DRUGPlacebo

Sodium chloride 0.9% 100ml given over 10minutes, 10 minutes prior to electroconvulsive therapy.


Locations(1)

Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern

Bern, Switzerland

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NCT04828226


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