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

Who is this study for? Adult patients with bipolar disorder, major depressive disorder, catatonia, or delirium post seizure
What treatments are being studied? Clonidine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged 18 and more;

• Scheduled for an elective series of ambulatory ECT sessions at the University Hospital Bern;

• Informed Consent as documented by signature (Appendix Informed Consent Form).

Locations
Other Locations
Switzerland
Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern
RECRUITING
Bern
Contact Information
Primary
Christian M Beilstein, MD
Christian.Beilstein@insel.ch
+41 31 632 24 82
Backup
Patrick Y Wüthrich, Prof, MD
Patrich.Wuethrich@insel.ch
+41 31 632 24 81
Time Frame
Start Date: 2021-04-27
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 130
Treatments
Experimental: Intervention
The study drug (clonidine 2 mcg/kg) is diluted in 100 ml sodium chloride 0.9 % by trained post-anaesthesia care staff not involved in the study.~At admission, electrocardiogram, non-invasive blood pressure and pulse oximetry is installed, a peripheral venous line established and supplemental oxygen applied.~The study drug will be given intravenously over 10 minutes at least 10 minutes before induction of anaesthesia.~Electroconvulsive therapy will be conducted according to hospital standard (Etomidate 0.2 mg/kg, Suxamethonium 1.0 mg/kg, isolated limb technique, THYMATRON® SYSTEM IV, Somatics Inc., Lake Bluf, Illinois, USA) adjusted to the patient's condition. Seizure quality will be assessed, prolonged seizure activity terminated with propofol 0.2 - 0.3 mg/kg. Severe agitation (Richmond Agitation and Sedation Score (RASS) \> 1) needing intervention will be treated with propofol or lorazepam. Patients will be assessed for delirium using CAM-ICU at 20 minutes after induction.
Placebo_comparator: Control
The placebo will be created by diluting 1ml of sodium chloride 0.9% in 100ml of sodium chloride in a sterile manner prior to application. The container will be identically labelled as the verum. The placebo will be applied by the same team members named above via the same route (intravenously), with the same speed and the same timing. All other parts of the procedure are identical as to the procedure described above.
Related Therapeutic Areas
Sponsors
Collaborators: University of Bern
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov

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