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Completed

NCT Number: NCT02500225

Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy

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.

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Key information

Conditions

Anesthesia ECT

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etomidate

Drug

0.2 mg/kg etomidate

Other names: Hypnomidate

Sevoflurane

Drug

8% Sevoflurane

Other names: Sevorane

Primary outcomes

  1. Motor (EMG) seizure duration

    Time frame: intraoperative

    Motor seizure duration in electroconvulsive therapy

  2. electroencephalography (EEG) seizure duration

    Time frame: intraoperative

    seizure duration in electroconvulsive therapy

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2015
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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