Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy

January 21, 2019 updated by: Ülkü Özgül, Inonu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Etomidate
0.2 mg/kg etomidate during anesthesia induction
Drug: Etomidate
0.2 mg/kg etomidate
Other Names:
  • Hypnomidate
Drug: Sevoflurane
8% Sevoflurane
Other Names:
  • Sevorane
Active Comparator: 8% sevoflurane
Sevoflurane 8% concentration during anesthesia induction
Drug: Etomidate
0.2 mg/kg etomidate
Other Names:
  • Hypnomidate
Drug: Sevoflurane
8% Sevoflurane
Other Names:
  • Sevorane

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
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
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Study Director: Ulku Ozgul, MD, Inönü University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ulku 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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