Three Anaesthesic Method in Electroconvulsive Theraphy

Study Overview
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Brief Summary
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To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT.

Detailed Description
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The purpose of this study is to compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration, postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery profiles in ECT.

Official Title
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Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Propofol
* Drug: Remifentanil and propofol
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients, Patients scheduled for six ECT sessions for a variety of psychiatric conditions (major depression, schizophrenia) Exclusion Criteria: Involuntary patient status Patients with known or self-declared needle or mask phobia Pregnancy Asthma Cerebrovascular disease, History of myocardial infarction in the previous 6 months, Atrial fibrillation or flutter,heart block, A known or family history of reactions to the study drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: propofol (Group P)<br>The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction | Drug: Propofol<br>* 1 mg/kg propofol IV (over 15 sec) during anesthesia induction<br>* Other names: Intravenous anesthetic agent;|
| Active Comparator: remifentanil and propofol (Group R)<br>Patients in Group R received remifentanil 1 µg/kg IV (over 60 sec) and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction | Drug: Remifentanil and propofol<br>* 1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction<br>* Other names: Opioid and intravenous anesthetic agent;|
| Active Comparator: sevoflurane (Group S)<br>In Group S, sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered, at which time it was stopped. | Drug: Sevoflurane<br>* Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered<br>* Other names: Volatil anesthetic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure duration | After anesthesia induction patients were administered electrical stimulation and seizure duration were measured. | The patients were observed about seizure up to ten minutes after electrical stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postictal suppression index | After anesthesia induction, patients were administered electrical stimulation. Then, postictal suppression index, a parameter that shows seizure quality, was determined from seizure records. | completing seizure in one hour | 
| Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands) | The time from the end of succinylcholine administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded. | after seizure in one hour in operation room. | 
| Hemodynamic variables | During perioperative period: Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended. | Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended. | 

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