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

Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Electroconvulsive Therapy
• Intervention / Treatment: Drug: Propofol; Drug: Propofol+Remifentanil; Drug: Propofol+Ketamine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Propofol; anesthesia will induced 1 mg/kg propofol	Drug: Propofol; 1 mg/kg propofol; Other Names: Diprivan
Active Comparator: Group propofol/remifentanil; anesthesia will induced 0.5 mg/kg propofol and 1 µg/kg remifentanil	Drug: Propofol+Remifentanil; 0.5 mg/kg propofol+0.5 mg/kg remifentanil; Other Names: Propofol+Ultiva
Active Comparator: Group propofol/ketamine; anesthesia will induced propofol 0.5 mg/kg and ketamine 0.5 mg/kg	Drug: Propofol+Ketamine; 0.5 mg/kg propofol and 0.5 mg/kg ketamine; Other Names: Propofol+Ketalar

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Ulku Ozgul, Ass.Prof., Inonu University Faculty of Medicine

Publications and helpful links

General Publications

• Erdogan Kayhan G, Yucel A, Colak YZ, Ozgul U, Yologlu S, Karlidag R, Ersoy MO. Ketofol (mixture of ketamine and propofol) administration in electroconvulsive therapy. Anaesth Intensive Care. 2012 Mar;40(2):305-10. doi: 10.1177/0310057X1204000214.
• Begec Z, Erdogan Kayhan G, Toprak HI, Sahin T, Konur H, Colak C, Durmus M, Ersoy MO. Sevoflurane alone and propofol with or without remifentanil for electroconvulsive therapy-a randomised, crossover study. Anaesth Intensive Care. 2013 Mar;41(2):202-6. doi: 10.1177/0310057X1304100209.

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: ketamine; propofol; remifentanil
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Ketamine; Remifentanil; Propofol
• Other Study ID Numbers: Ulku 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO