Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

Study Overview
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Brief Summary
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The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and Tp-e interval during in patients with major depression.

Detailed Description
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Patients enrolled in the study are randomly allocated by computer-generated random numbers to receive either sevoflurane or ketamine for their initial ECT session. They subsequently receive an alternative study drug in their next session, continuing to alternate between drugs at each session until the sixth session. In group S, sevoflurane are initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus is delivered, In group K, ketamine are given to 1mg/kg ıv bolus. Electrical stimulus is delivered via bilateral frontotemporal electrodes.The mean arterial pressure (MAP), HR, and ECG are recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively).The QT interval and Tp-e interval are measured by one author, who was unaware of group allocation.

Official Title
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The Effects of Sevoflurane or Ketamine on QTc Interval During Electroconvulsive Therapy

Conditions
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Major Depression, Electroconvulsive Therapy

Intervention / Treatment
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* Drug: Sevoflurane
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unpremedicated American Society of Anesthesiologists (ASA) I-II the patients Major depressions patients scheduled for ECT sessions Exclusion Criteria: pregnant with permanent pacemakers, diabetes mellitus, atrial fibrillation, electrolyte imbalance, patients taking antiarrhythmics and β-blockers.

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group S<br>In group S, sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered, at which time it was turned off. | Drug: Sevoflurane<br>* sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered<br>* Other names: Volatile agent;|
| Active Comparator: Group K<br>In group K, ketamine was given to 1mg/kg ıv bolus. | Drug: Ketamine<br>* ketamine was given to 1mg/kg ıv bolus<br>* Other names: Intravenous anesthetic agent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation Of QT interval | ECG were recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively)during ECT anesthesia with sevoflurane and ketamine.The QT interval was measured by one author, who was unaware of group allocation. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Tp-e interval | ECG were recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively)during ECT anesthesia with sevoflurane and ketamine.The Tp-e interval was measured by one author, who was unaware of group allocation. | 10 minutes | 
| Seizure durations | The duration of the EEG seizure was recorded from the EEG trace, and the peak heart rate (HR) during the convulsion was recorded from the ECG. | 120 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sevoflurane, ketamine, QT interval