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Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy

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ClinicalTrials.gov Identifier: NCT02500225
Recruitment Status : Completed
First Posted : July 16, 2015
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ülkü Özgül, 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.

Condition or disease Intervention/treatment Phase
Anesthesia ECT Drug: Etomidate Drug: Sevoflurane Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ulku Ozgul, Associate Professor, Inonu University, Department of Anesthesiology and Reanimation
Actual Study Start Date : January 2017
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Etomidate
0.2 mg/kg etomidate during anesthesia induction
Drug: Etomidate
0.2 mg/kg etomidate
Other Name: Hypnomidate

Drug: Sevoflurane
8% Sevoflurane
Other Name: Sevorane

Active Comparator: 8% sevoflurane
Sevoflurane 8% concentration during anesthesia induction
Drug: Etomidate
0.2 mg/kg etomidate
Other Name: Hypnomidate

Drug: Sevoflurane
8% Sevoflurane
Other Name: Sevorane




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500225


Sponsors and Collaborators
Inonu University
Investigators
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Study Director: Ulku Ozgul, MD Inonu University School of Medicine
Publications of Results:
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Responsible Party: Ülkü Özgül, Associate Professor, Inonu University
ClinicalTrials.gov Identifier: NCT02500225    
Other Study ID Numbers: Ulku 1
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by Ülkü Özgül, Inonu University:
Etomidate
Sevoflurane
Additional relevant MeSH terms:
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Sevoflurane
Etomidate
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous