Turgut Ozal Medical Center Department of Anesthesiology and Reanimation
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Inonu University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- seizure duration
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group SK
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.
Intervention: Sevoflurane (Drug)
Group SK
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.
Intervention: Ketamine (Drug)
Group SS
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.
Intervention: Sevoflurane (Drug)
Group SS
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.
Intervention: Saline (Drug)
Outcomes
Primary Outcomes
seizure duration
Time Frame: During electroconvulsive therapy (30 minutes)
the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm.
Secondary Outcomes
- Heart rate (HR)(During Electroconvulsive therapy (30 minutes))
- Mean arterial pressure (MAP)(During Electroconvulsive therapy (30 minutes))
Investigators
Feray Erdil
Associated Professor
Inonu University