Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy

Study Overview
=================
Brief Summary
-----------------
The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.

Detailed Description
-----------------
Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.

Official Title
-----------------
Turgut Ozal Medical Center Department of Anesthesiology and Reanimation

Conditions
-----------------
Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Sevoflurane
* Drug: Ketamine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major depressive patients Exclusion Criteria: Pregnancy Have a history of myocardial infarction in the previous six months Atrial fibrillation or flutter Heart block Unregulated hypertension Cerebrovascular diseases A known drug allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group SK<br>Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner. | Drug: Sevoflurane<br>* Inhalation anesthetic agent<br>* Other names: Sevoflurane (sevorane);Drug: Ketamine<br>* Intravenous anesthetic agent<br>* Other names: Ketamine (Ketalar) 50mg/mL injection;|
| Placebo Comparator: Group SS<br>Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner. | Drug: Sevoflurane<br>* Inhalation anesthetic agent<br>* Other names: Sevoflurane (sevorane);Drug: Saline<br>* Isotonic solution for placebo group<br>* Other names: Isotonic solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seizure duration | the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm. | During electroconvulsive therapy (30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure (MAP) | Mean arterial pressure (MAP) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). | During Electroconvulsive therapy (30 minutes) | 
| Heart rate (HR) | Heart rate (HR) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). | During Electroconvulsive therapy (30 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electroconvulsive therapy; sevoflurane; ketamine