Comparison of Propofol, Propofol-remifentanil and Propofol-ketamine Anesthesia During Electroconvulsive Therapy
Condition: Anesthesia; Electroconvulsive Therapy
Study type: Interventional
Phase: Phase 4

Summary: 
      Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and
      other psychiatric diseases. Currently, most ECT procedures are carried out with muscle
      paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic
      drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to
      establish an accurate balance between adequate anaesthesia depth and optimal seizure
      duration.

      We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone, propofol
      with remifentanil and propofol with ketamine), with respect to seizure duration and seizure
      quality in patients undergoing electroconvulsive therapy.
    

Detailed description: 
      In this study, 45 patients of American Society of Anesthesiologists (ASA) physical status
      I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia.
      Seven consecutive ECT sessions will evaluated in this study. Exclusion criteria; pregnancy,
      cerebrovascular disease, epilepsy, unstable cardiovascular disease, chronic obstructive
      pulmonary disease, and renal or hepatic failure.

      Electrocardiogram (ECG), noninvasive arterial blood pressure, and peripheral oxygen
      saturation (SpO2) measurements will utilized along with standard monitoring techniques in the
      operating room for patients who did not receive pre-operative medication. A 20-gauge
      intravenous cannula will placed before induction of patients. Each patient will receive
      either propofol 1 mg/kg alone (Group P), propofol 0.5 mg/kg and remifentanil 1 µg/kg (Group
      R), or propofol 0.5 mg/kg and ketamine 0.5 mg/kg (Group K) for their all electroconvulsive
      therapy session. A pneumatic tourniquet will applied to the arm and then will inflated to
      isolate blood circulation and allow for an accurate assessment of the motor seizure.
      Rocuronium (0.3 mg/kg bolus) will administered intravenously and ventilation will assisted
      using a facemask and 100% oxygen in three groups. Electrostimulus will performed via
      bifrontotemporal electrodes with a Thymatron System IV ECT Instrument (Somatics Inc.; Lake
      Bluff, IL, USA) by a psychiatrist who was blind to the study groups. In the initial session,
      patients will received ECT with 30-50% of the maximum output stimulus, depending on the
      preference of the psychiatrist. Thereafter, the same psychiatrist will arranged the stimulus
      amplitudes according to the clinical results of each patient.

      The duration of the EEG, motor seizure, and postictal suppression index (PSI) will recorded
      from the EEG and electromyography traces. Heart rate (HR), systolic blood pressure (SBP),
      diastolic blood pressure (DBP), mean blood pressure (MBP), and peripheral oxygen saturation
      (SpO2) values will taken before anesthesia induction (Tbaseline), after the induction (T0),
      and following the ECT session at 1 (T1), 3 (T3), and 10 (T10) minutes. Time from the end of
      rocuronium administration to the time of recovery of spontaneous breathing, time of eye
      opening, and time of obeying verbal commands will recorded. The presence of complications,
      such as arrhythmia, laryngospasm, and agitation, will also recorded.
    

Intervention name(s): Propofol; Propofol+Remifentanil; Propofol+Ketamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 mg/kg propofol; 0.5 mg/kg propofol+0.5 mg/kg remifentanil; 0.5 mg/kg propofol and 0.5 mg/kg ketamine
Other intervention name(s): Diprivan; Propofol+Ultiva; Propofol+Ketalar
Intervention MeSH terms: Ketamine; Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: propofol; ketamine; remifentanil