Clinical trial NCT02500225: Comparison the Effects of Etomidate and Sevoflurane During Electroconvulsive Therapy
Official title: Ulku Ozgul, Associate Professor, Inonu University, Department of Anesthesiology and Reanimation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
ECT
Keywords: Etomidate
Sevoflurane
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Motor (EMG) seizure duration
timeFrame: intraoperative
measure: electroencephalography (EEG) seizure duration
timeFrame: intraoperative
Secondary outcomes:
measure: heart rate (HR),
timeFrame: (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
measure: mean arterial pressure (MAP)
timeFrame: (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
measure: recovery times
timeFrame: (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
Other outcomes:
Locations:
Study officials:
affiliation: Inonu University School of Medicine
name: Ulku Ozgul, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.