Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy

NCT ID: NCT02500225

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Anesthesia ECT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Etomidate

0.2 mg/kg etomidate during anesthesia induction

Group Type ACTIVE_COMPARATOR

Etomidate

Intervention Type DRUG

0.2 mg/kg etomidate

Sevoflurane

Intervention Type DRUG

8% Sevoflurane

8% sevoflurane

Sevoflurane 8% concentration during anesthesia induction

Group Type ACTIVE_COMPARATOR

Etomidate

Intervention Type DRUG

0.2 mg/kg etomidate

Sevoflurane

Intervention Type DRUG

8% Sevoflurane

Interventions

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Etomidate

0.2 mg/kg etomidate

Intervention Type DRUG

Sevoflurane

8% Sevoflurane

Intervention Type DRUG

Other Intervention Names

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Hypnomidate Sevorane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Ülkü Özgül

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ulku Ozgul, MD

Role: STUDY_DIRECTOR

Inonu University School of Medicine

References

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Janouschek H, Nickl-Jockschat T, Haeck M, Gillmann B, Grozinger M. Comparison of methohexital and etomidate as anesthetic agents for electroconvulsive therapy in affective and psychotic disorders. J Psychiatr Res. 2013 May;47(5):686-93. doi: 10.1016/j.jpsychires.2012.12.019. Epub 2013 Feb 9.

Reference Type RESULT
PMID: 23399487 (View on PubMed)

Toprak HI, Gedik E, Begec Z, Ozturk E, Kaya B, Ersoy MO. Sevoflurane as an alternative anaesthetic for electroconvulsive therapy. J ECT. 2005 Jun;21(2):108-10. doi: 10.1097/01.yct.0000166633.73555.28.

Reference Type RESULT
PMID: 15905753 (View on PubMed)

Other Identifiers

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Ulku 1

Identifier Type: -

Identifier Source: org_study_id

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