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

Phase 4

• Conditions: Haemodynamic Rebound
• Interventions: Drug: Sevoflurane; Drug: Remifentanil; Drug: Saline

• Registration Number: NCT02271555
• Lead Sponsor: Inonu University

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2014-10
• Study Start: 2014-10
• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-20
• Last Update Submitted: 2014-10-20
• Study First Posted: 2014-10-22
• Last Update Posted: 2014-10-22
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sevoflurane-remifentanil (Group SR)	Remifentanil	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.
sevoflurane-saline (Group SS)	Saline	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.
sevoflurane-remifentanil (Group SR)	Sevoflurane	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.
sevoflurane-saline (Group SS)	Sevoflurane	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.

Primary Outcome Measures

Name	Time	Method
The effects of remifentanil on the heart rate after electroconvulsive therapy	20 minute	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).

Secondary Outcome Measures

Name	Time	Method
Seizure duration	20 minute	During electroconvulsive therapy
The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy	20 minute	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).

Trial Locations

Locations (1)

Turgut Ozal Medical Center; 🇹🇷 Malatya, Turkey