Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy

Study Overview
=================
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.

Official Title
-----------------
Ulku Ozgul, Associate Professor, Inonu University, Department of Anesthesiology and Reanimation

Conditions
-----------------
Anesthesia, ECT

Intervention / Treatment
-----------------
* Drug: Etomidate
* Drug: Sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Etomidate<br>0.2 mg/kg etomidate during anesthesia induction | Drug: Etomidate<br>* 0.2 mg/kg etomidate<br>* Other names: Hypnomidate;Drug: Sevoflurane<br>* 8% Sevoflurane<br>* Other names: Sevorane;|
| Active Comparator: 8% sevoflurane<br>Sevoflurane 8% concentration during anesthesia induction | Drug: Etomidate<br>* 0.2 mg/kg etomidate<br>* Other names: Hypnomidate;Drug: Sevoflurane<br>* 8% Sevoflurane<br>* Other names: Sevorane;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor (EMG) seizure duration | Motor seizure duration in electroconvulsive therapy | intraoperative | 
| electroencephalography (EEG) seizure duration | seizure duration in electroconvulsive therapy | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate (HR), | heart rate in electroconvulsive therapy | (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 | 
| mean arterial pressure (MAP) | MAP will be measured by a blood pressure cuff | (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 | Recovery times will be assessed with spontaneous breathing, eye opening, obeying commands 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Etomidate, Sevoflurane