Clonidine to Prevent Delirium After Electroconvulsive Therapy. (ECaTa)
Major Depressive Disorder, Catatonia, Bipolar Disorder
About this trial
This is an interventional prevention trial for Major Depressive Disorder focused on measuring Electroconvulsive Therapy, ECT, Clonidine, Postictal Delirium, Postseizure Delirium, Postictal Agitation, Postseizure Agitation, CAM-ICU, RASS
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Contraindications to the study drug, e. g. known allergy or hypersensitivity, hypotension, bradycardia, higher grade atrioventricular block;
- On regular Clonidine for another indication (e.g. arterial hypertension)
- Patients undergoing emergency ECT;
- Unable to consent (incapable of judgment, next-of-kin consent necessary or under tutelage);
- Inability to follow the procedures of the study, e. g. due to language barrier;
- Previous enrolment into the current study;
- Participation in another study with investigational drug within the 30 days preceding and during the present study;
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
- Women who are pregnant or breast feeding;
- Intention to become pregnant during the course of the study;
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration (and 4 weeks thereafter), such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
Sites / Locations
- Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of BernRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intervention
Control
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.
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.