Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy

Phase 4

• Conditions: Depressive Disorder
• Interventions: Drug: Sevoflurane; Drug: Ketamine; Drug: Saline

• Registration Number: NCT02267980
• Lead Sponsor: Inonu University

Brief Summary

The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.

Detailed Description

Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.

Study Timeline

• Study Start: 2014-07
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-10-09
• Study First Submitted QC: 2014-10-15
• Last Update Submitted: 2014-10-15
• Study First Posted: 2014-10-20
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Major depressive patients

Exclusion Criteria

• Pregnancy
• Have a history of myocardial infarction in the previous six months
• Atrial fibrillation or flutter
• Heart block
• Unregulated hypertension
• Cerebrovascular diseases
• A known drug allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group SK	Ketamine	Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner.
Group SS	Sevoflurane	Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner.
Group SK	Sevoflurane	Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner.
Group SS	Saline	Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner.

Primary Outcome Measures

Name	Time	Method
seizure duration	During electroconvulsive therapy (30 minutes)	the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm.

Secondary Outcome Measures

Name	Time	Method
Heart rate (HR)	During Electroconvulsive therapy (30 minutes)	Heart rate (HR) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively).
Mean arterial pressure (MAP)	During Electroconvulsive therapy (30 minutes)	Mean arterial pressure (MAP) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively).

Trial Locations

Locations (1)

Turgut Ozal Medical Center; 🇹🇷 Malatya, Turkey