Use of Clonidine (Catapresan®) to Reduce Confusional States (Delirium) After Electroconvulsive Therapy: A Randomized, Placebo-Controlled, Triple-Blind Study at a Center
Summary description of the study
Electroconvulsive therapy is currently performed under general anesthesia. During the awakening phase, confusion and agitation states may occur, which usually disappear within 60 minutes. The patient has no memory of this state, but it can temporarily be a burden for the patient, relatives, and hospital staff, even posing a risk. Additionally, it is known that prolonged confusion states are associated with negative side effects such as a longer recovery time. The drug Clonidine (Catapresan®) has been successfully used for the treatment of hypertension since the 1960s and is approved in Switzerland for this indication. As a side effect, Clonidine has a calming effect by dampening the release of body’s own activating messengers such as adrenaline. We want to take advantage of this side effect and investigate how well prior medication with Clonidine can reduce confusion states after electroconvulsive therapy. The drug Clonidine is not formally approved for the treatment of confusion states, but it is frequently used in clinical practice and is also recommended by the relevant professional societies in their guidelines for this area of application. Furthermore, it is already known that drugs from the same substance class show good effects.
(BASEC)
Intervention under investigation
Patients will be randomly assigned to the treatment arm (administration of Clonidine via the venous access necessary for general anesthesia in addition to the usual infusion solution) or the control arm (administration of the usual infusion solution via the venous access necessary for general anesthesia). Electroconvulsive therapy will be performed identically in both arms. There are no additional examinations or burdens, except for a telephone interview after the last session.
(BASEC)
Disease under investigation
Confusion states after electroconvulsive therapy, which is applied in treatment-resistant psychiatric conditions such as depression, bipolar disorder, or catatonia.
(BASEC)
All individuals aged 18 years and older who are scheduled for a series of electroconvulsive therapies (usually a series of 12 sessions) at the Department of Anesthesiology and Pain Therapy of the Inselspital Bern and have personally given their consent for the necessary general anesthesia can participate. (BASEC)
Exclusion criteria
Participation is not possible in case of guardianship, pregnancy, breastfeeding, or a contraindication for Catapresan (known allergy or intolerance, certain heart rhythm disorders, low blood pressure). This will be examined in detail by the study physician. (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Inselgruppe AG, Universitätsklinik für Anästhesiologie und Schmerzmedizin
(BASEC)
Contact
Contact Person Switzerland
Christian M. Beilstein
+41 31 632 24 83
Christian.Beilstein@clutterinsel.chUniversitätsklinik für Anästhesiologie und Schmerzmedizin, Inselspital Bern
(BASEC)
General Information
Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern,
+41 31 632 24 82;+41 31 632 24 83
Christian.Beilstein@clutterinsel.ch(ICTRP)
Scientific Information
Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern,
+41 31 632 24 82;+41 31 632 24 83
Christian.Beilstein@clutterinsel.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
15.03.2021
(BASEC)
ICTRP Trial ID
NCT04828226 (ICTRP)
Official title (approved by ethics committee)
Clonidine to prevent postictal delirium after ElectroConvulsive Therapy: a randomised, placebo-controlled, triple-blind, single-centre trial (BASEC)
Academic title
Clonidine to Prevent Postictal Delirium After ElectroConvulsive Therapy: a Randomised, Placebo-controlled, Triple-blind, Single-centre Trial. (ICTRP)
Public title
Clonidine to Prevent Delirium After Electroconvulsive Therapy. (ICTRP)
Disease under investigation
Major Depressive Disorder;Catatonia;Bipolar Disorder;Delirium Postseizure (ICTRP)
Intervention under investigation
Drug: Clonidine;Drug: Placebo (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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. (ICTRP)
not available
Primary and secondary end points
Incidence of delirium after electroconvulsive therapy over all (twelve) ECT sessions (ICTRP)
Incidence of mild agitation;Incidence of severe agitation;Use of rescue medication;Duration of seizure activity;Quality of seizure activity;Seizure Quality Index;Need for seizure terminating medication;Total number of electroconvulsive therapy sessions;Reason for terminating or continuing the electroconvulsive series;Length of post-anaesthesia care unit stay;Incidence of desaturation;Incidence of hypotension;Incidence of bradycardia;Cardiovascular changes needing intervention;Use of cardiovascular medication;Adverse events potentially attributable to ECT;Adverse events potentially attributable to Study Drug (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
University of Bern (ICTRP)
Additional contacts
Patrick Y W?thrich, Prof, MD;Christian M Beilstein, MD;Christian M Beilstein, MD, Christian.Beilstein@insel.ch, +41 31 632 24 82;+41 31 632 24 83, Department of Anaesthesiology and Pain Medicine, Bern University Hospital, University of Bern, (ICTRP)
Secondary trial IDs
BECD-3-21 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04828226 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available