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

Inonu University

Status and phase: Unknown; Phase 4

Conditions: Depressive Disorder

Treatments: Drug: Ketamine; Drug: Sevoflurane; Drug: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02267980

Inonu 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Group SK

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane

Drug: Ketamine

Group SS

Placebo Comparator group

Description:

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.

Treatment:

Drug: Saline

Drug: Sevoflurane