Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy

Phase 4

Completed

• Conditions: Anesthesia; ECT
• Interventions: Drug: Etomidate; Drug: Sevoflurane

• Registration Number: NCT02500225
• Lead Sponsor: Inonu University

Brief Summary

The purpose of the study was to investigate the effects of etomidate or sevoflurane used in electroconvulsive therapy (ECT) on duration of seizure, hemodynamic response and recovery profiles.

Detailed Description

Twenty-five patients will be a total of 150 ECT treatments in this prospective, double-blinded, crossover study. Each patient will receive either 0.2 mg/kg etomidate (Group 1) or 8% sevoflurane (Group 2) in 100% oxygen at 6 L/min fresh gas flow until loss of consciousness for their initial electroconvulsive therapy session. In subsequent sessions, patients will receive the alternative sevoflurane concentration and then alternated between doses until the sixth session. Muscle paralysis will achieve with 1 mg/kg succinylcholine. Motor (EMG) and electroencephalography seizure duration (EEG), heart rate (HR) and mean arterial pressure (MAP) values, and recovery times will recorde.

Study Timeline

• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-16
• Study Start: 2017-01
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Study include 25 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who schedule for ECT sessions under general anesthesia

Exclusion Criteria

• Pregnancy
• Cerebrovascular disease
• Epilepsy
• Unstable cardiovascular disease
• Chronic obstructive pulmonary disease; and
• Renal or hepatic failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
8% sevoflurane	Sevoflurane	Sevoflurane 8% concentration during anesthesia induction
Etomidate	Etomidate	0.2 mg/kg etomidate during anesthesia induction
8% sevoflurane	Etomidate	Sevoflurane 8% concentration during anesthesia induction
Etomidate	Sevoflurane	0.2 mg/kg etomidate during anesthesia induction

Primary Outcome Measures

Name	Time	Method
Motor (EMG) seizure duration	intraoperative	Motor seizure duration in electroconvulsive therapy
electroencephalography (EEG) seizure duration	intraoperative	seizure duration in electroconvulsive therapy

Secondary Outcome Measures

Name	Time	Method
mean arterial pressure (MAP)	(approximately 5 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	MAP will be measured by a blood pressure cuff
heart rate (HR),	(approximately 5 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	heart rate in electroconvulsive therapy
recovery times	(approximately 5 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 will be assessed with spontaneous breathing, eye opening, obeying commands times