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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Inonu University, Turgut Ozal Medical Center, Department of Anesthesiology and Reanimation Malatya

Conditions
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Haemodynamic Rebound

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Remifentanil
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sevoflurane-remifentanil (Group SR)<br>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. | Drug: Sevoflurane<br>* Anesthetic induction will be achieved via 8% sevoflurane<br>* Other names: Sevorane;Drug: Remifentanil<br>* After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.<br>* Other names: Ultiva;|
| Placebo Comparator: sevoflurane-saline (Group SS)<br>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. | Drug: Sevoflurane<br>* Anesthetic induction will be achieved via 8% sevoflurane<br>* Other names: Sevorane;Drug: Saline<br>* After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus.<br>* Other names: 0.9% isotonic solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of remifentanil on the heart rate after electroconvulsive therapy | 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). | 20 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure duration | During electroconvulsive therapy | 20 minute | 
| The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy | 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). | 20 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electroconvulsive therapy, sevoflurane, remifentanil