Effects of Low-dose Ketamine as an Adjunct to Propofol-based Anesthesia for Electroconvulsive Therapy

• Status: Completed
• Trial end date: 2019-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Ketamine has been used successfully as the sole medication for anesthesia in the setting of electroconvulsive therapy (ECT), and has more recently been studied as an adjunct agent in combination with propofol (the most commonly used anesthetic agent) to induce anesthesia for ECT. New literature postulates an anti-depressant effect of ketamine, which in ECT specifically may be helpful with regards to the overall goals of therapy (i.e. ECT indicated for severe or treatment-resistant depression).

Current research focusing on ketamine with respect to its anti-depressant effect suggests it may even represent an alternative to ECT. This study will seek to determine whether ketamine when used in low-doses as an adjunct to propofol-based anesthesia for ECT has anti-depressant effects and whether it influences the characteristics of recovery from anesthesia in the ECT setting (i.e. vital sign parameters such as blood pressure and heart rate, quality of recovery, etc.).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Collaborator: Alberta Health Services
• Treatments: Ketamine; Propofol

Criteria

Inclusion Criteria:

• referred for ECT with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of major depressive disorder

• considered American Society of Anesthesiologists (ASA) Physical Class I - III

• baseline MADRS score greater than 24 (i.e. at least moderate to severe depression)

• a "first" or "new" episode of depression which has lasted not more than 3 months and requires ECT treatment as judged by a psychiatrist

Exclusion Criteria:

• ASA Class IV or V as judged by the anesthesiologist

• Any ECT treatment in the previous three months

• Inability or refusal to provide informed consent

• A history of allergic reactions, hypersensitivity, or intolerance to anesthetics or their constituents used in the study (ketamine, propofol, egg phosphatide, soybean oil)

• Anyone taking medications considered contraindicated for ECT or for general anesthesia

• Presence of any of the following DSM-IV diagnoses: Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), abuse of opiates, amphetamines, barbiturates, cocaine, cannabis, or hallucinogen abuse in the 4 weeks prior to enrolment, pervasive developmental disorder, dementia

• Significant medical condition that would contraindicate the use of ketamine, propofol or that is untreated and would need urgent attention (as determined by treating physician)

• Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or propofol

• Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator

• Patients with increased risk of laryngospasm (such as active pulmonary infection, upper respiratory infection, asthma), increased intracranial pressure, glaucoma, thyroid disease/hyperthyroidism

• Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator

• Pregnancy (or female of child-bearing age not using adequate contraception) or lactation

• Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements