The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy

Inonu University

Status and phase: Unknown; Phase 4

Conditions: Haemodynamic Rebound

Treatments: Drug: Sevoflurane; Drug: Saline; Drug: Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02271555

Inonu 3

Details and patient eligibility

About

The investigators will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression

Full description

Major depressive patients will enrolled this trial. Mean arterial pressure (MAP) and heart rate (HR) and peripheral oxygen saturation values will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively). The peak heart rate during the seizure will be recorded from the Electrocardiogram.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major depressive patients

Exclusion criteria

• younger than 18 years, pregnant, had a history of myocardial infarction in the previous six months, atrial fibrillation or flutter, heart block, unregulated hypertension, cerebrovascular diseases, known drug allergy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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58 participants in 2 patient groups, including a placebo group

sevoflurane-remifentanil (Group SR)

Active Comparator group

Description:

Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.

Treatment:

Drug: Remifentanil

Drug: Sevoflurane

sevoflurane-saline (Group SS)

Placebo Comparator group

Description:

Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. Placebo is 0.9% saline. After the loss of consciousness saline will be administered to Group sevoflurane-saline in the form of intravenous bolus.

Treatment:

Drug: Saline

Drug: Sevoflurane