Comparison of Propofol, Propofol-remifentanil and Propofol-ketamine Anesthesia During Electroconvulsive Therapy

Study Overview
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Brief Summary
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Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and other psychiatric diseases. Currently, most ECT procedures are carried out with muscle paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to establish an accurate balance between adequate anaesthesia depth and optimal seizure duration. We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone, propofol with remifentanil and propofol with ketamine), with respect to seizure duration and seizure quality in patients undergoing electroconvulsive therapy.

Detailed Description
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In this study, 45 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia. Seven consecutive ECT sessions will evaluated in this study. Exclusion criteria; pregnancy, cerebrovascular disease, epilepsy, unstable cardiovascular disease, chronic obstructive pulmonary disease, and renal or hepatic failure. Electrocardiogram (ECG), noninvasive arterial blood pressure, and peripheral oxygen saturation (SpO2) measurements will utilized along with standard monitoring techniques in the operating room for patients who did not receive pre-operative medication. A 20-gauge intravenous cannula will placed before induction of patients. Each patient will receive either propofol 1 mg/kg alone (Group P), propofol 0.5 mg/kg and remifentanil 1 µg/kg (Group R), or propofol 0.5 mg/kg and ketamine 0.5 mg/kg (Group K) for their all electroconvulsive therapy session. A pneumatic tourniquet will applied to the arm and then will inflated to isolate blood circulation and allow for an accurate assessment of the motor seizure. Rocuronium (0.3 mg/kg bolus) will administered intravenously and ventilation will assisted using a facemask and 100% oxygen in three groups. Electrostimulus will performed via bifrontotemporal electrodes with a Thymatron System IV ECT Instrument (Somatics Inc.; Lake Bluff, IL, USA) by a psychiatrist who was blind to the study groups. In the initial session, patients will received ECT with 30-50% of the maximum output stimulus, depending on the preference of the psychiatrist. Thereafter, the same psychiatrist will arranged the stimulus amplitudes according to the clinical results of each patient. The duration of the EEG, motor seizure, and postictal suppression index (PSI) will recorded from the EEG and electromyography traces. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and peripheral oxygen saturation (SpO2) values will taken before anesthesia induction (Tbaseline), after the induction (T0), and following the ECT session at 1 (T1), 3 (T3), and 10 (T10) minutes. Time from the end of rocuronium administration to the time of recovery of spontaneous breathing, time of eye opening, and time of obeying verbal commands will recorded. The presence of complications, such as arrhythmia, laryngospasm, and agitation, will also recorded.

Official Title
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Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Conditions
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Anesthesia, Electroconvulsive Therapy

Intervention / Treatment
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* Drug: Propofol
* Drug: Propofol+Remifentanil
* Drug: Propofol+Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study include 45 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who scheduled for ECT sessions under general anesthesia Exclusion Criteria: Pregnancy Cerebrovascular disease Epilepsy Unstable cardiovascular disease Chronic obstructive pulmonary disease Renal or hepatic failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Propofol<br>anesthesia will induced 1 mg/kg propofol | Drug: Propofol<br>* 1 mg/kg propofol<br>* Other names: Diprivan;|
| Active Comparator: Group propofol/remifentanil<br>anesthesia will induced 0.5 mg/kg propofol and 1 µg/kg remifentanil | Drug: Propofol+Remifentanil<br>* 0.5 mg/kg propofol+0.5 mg/kg remifentanil<br>* Other names: Propofol+Ultiva;|
| Active Comparator: Group propofol/ketamine<br>anesthesia will induced propofol 0.5 mg/kg and ketamine 0.5 mg/kg | Drug: Propofol+Ketamine<br>* 0.5 mg/kg propofol and 0.5 mg/kg ketamine<br>* Other names: Propofol+Ketalar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seizure activity | Motor (EMG) and electroencephalogram (EEG) seizure durations | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate (HR) | heart rate | (approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes | 
| mean arterial pressure (MAP) | mean arterial pressure | (approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes | 
| recovery times | Recovery times will be assessed with spontaneous breathing, eye opening, obeying | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, ketamine, remifentanil