NCT02500225

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2017

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1 month

First QC Date

July 9, 2015

Last Update Submit

January 21, 2019

Conditions

AnesthesiaECT

Keywords

EtomidateSevoflurane

Outcome Measures

Primary Outcomes (2)

  • Motor (EMG) seizure duration

    Motor seizure duration in electroconvulsive therapy

    intraoperative

  • electroencephalography (EEG) seizure duration

    seizure duration in electroconvulsive therapy

    intraoperative

Secondary Outcomes (3)

  • heart rate (HR),

    (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)

    (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

    (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

Study Arms (2)

Etomidate

ACTIVE COMPARATOR

0.2 mg/kg etomidate during anesthesia induction

Drug: EtomidateDrug: Sevoflurane

8% sevoflurane

ACTIVE COMPARATOR

Sevoflurane 8% concentration during anesthesia induction

Drug: EtomidateDrug: Sevoflurane

Interventions

EtomidateDRUG

0.2 mg/kg etomidate

Also known as: Hypnomidate
8% sevofluraneEtomidate
SevofluraneDRUG

8% Sevoflurane

Also known as: Sevorane
8% sevofluraneEtomidate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Cerebrovascular disease
  • Epilepsy
  • Unstable cardiovascular disease
  • Chronic obstructive pulmonary disease; and
  • Renal or hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23399487RESULT

  • 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.

    PMID: 15905753RESULT

MeSH Terms

Interventions

EtomidateSevoflurane

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Ulku Ozgul, MD

    Inonu University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 16, 2015

Study Start

January 1, 2017

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 23, 2019

Record last verified: 2019-01