Overview

This trial is active, not recruiting.

Conditions anesthesia, ect
Treatments etomidate, sevoflurane
Phase phase 4
Sponsor Inonu University
Start date July 2015
End date September 2016
Trial size 25 participants
Trial identifier NCT02500225, Ulku 1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
0.2 mg/kg etomidate during anesthesia induction
etomidate Hypnomidate
0.2 mg/kg etomidate
sevoflurane Sevorane
8% Sevoflurane
(Active Comparator)
Sevoflurane 8% concentration during anesthesia induction
etomidate Hypnomidate
0.2 mg/kg etomidate
sevoflurane Sevorane
8% Sevoflurane

Primary Outcomes

Measure
Motor (EMG) seizure duration
time frame: intraoperative
electroencephalography (EEG) seizure duration
time frame: intraoperative

Secondary Outcomes

Measure
heart rate (HR),
time frame: (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)
time frame: (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
time frame: (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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Ulku Ozgul, Associate Professor, Inonu University, Department of Anesthesiology and Reanimation
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Inonu University.