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

NCT ID: NCT02819375

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-03-31

Brief Summary

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

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.

Conditions

Anesthesia; Electroconvulsive Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group Propofol

anesthesia will induced 1 mg/kg propofol

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

1 mg/kg propofol

Group propofol/remifentanil

anesthesia will induced 0.5 mg/kg propofol and 1 µg/kg remifentanil

Group Type: ACTIVE_COMPARATOR

Propofol+Remifentanil

Intervention Type: DRUG

0.5 mg/kg propofol+0.5 mg/kg remifentanil

Group propofol/ketamine

anesthesia will induced propofol 0.5 mg/kg and ketamine 0.5 mg/kg

Group Type: ACTIVE_COMPARATOR

Propofol+Ketamine

Intervention Type: DRUG

0.5 mg/kg propofol and 0.5 mg/kg ketamine

Interventions

Propofol

1 mg/kg propofol

Intervention Type: DRUG

Propofol+Remifentanil

0.5 mg/kg propofol+0.5 mg/kg remifentanil

Intervention Type: DRUG

Propofol+Ketamine

0.5 mg/kg propofol and 0.5 mg/kg ketamine

Intervention Type: DRUG

Other Intervention Names

Diprivan; Propofol+Ultiva; Propofol+Ketalar

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Ülkü Özgül

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulku Ozgul, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Inonu University Faculty of Medicine

References

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.

Reference Type: RESULT

PMID: 22417026 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23530786 (View on PubMed)

Other Identifiers

Ulku 2

Identifier Type: -

Identifier Source: org_study_id