Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500225
• Other study ID #: Ulku 1
• Status: Completed
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: February 2017

Study information

• Verified date: January 2019
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• ECT

Intervention

Drug:
• Etomidate
0.2 mg/kg etomidate
• Sevoflurane
8% Sevoflurane

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

References & Publications (2)

Janouschek H, Nickl-Jockschat T, Haeck M, Gillmann B, Grözinger 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.jps — View Citation

Toprak HI, Gedik E, Begeç Z, Oztürk E, Kaya B, Ersoy MO. Sevoflurane as an alternative anaesthetic for electroconvulsive therapy. J ECT. 2005 Jun;21(2):108-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor (EMG) seizure duration	Motor seizure duration in electroconvulsive therapy	intraoperative
Primary	electroencephalography (EEG) seizure duration	seizure duration in electroconvulsive therapy	intraoperative
Secondary	heart rate (HR),	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
Secondary	mean arterial pressure (MAP)	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
Secondary	recovery times	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