Condition 1: Severe depressive episode without psychotic symptoms. Condition 2: Recurrent depressive disorder, current episode severe without psychotic symptoms. Condition 3: Anorexia nervosa. Condition 4: Atypical anorexia nervosa. Condition 5: Obsessive-compulsive disorder. Condition 6: Generalized anxiety disorder. Condition 7: Bipolar affective disorder, current episode severe depression without psychotic symptoms. Major depressive disorder, single episode, severe without psychotic features
Conditions
Interventions
Intervention 1: The first intervention group: The first intervention group consists of 52 patients receiving ketofol. Ketofol is prepared as a combination of ketamine and propofol
the ketamine dose is 0.2 mg per kilogram and the propofol dose is 0.5 mg per kilogram of patient weight. The chemical composition of ketamine is 2-(2-chlorophenyl)-2-(methylamino)cyclohexanone and pro
the dose is 1 mg per kilogram of patient weight. The chemical composition of propofol is 2,6-diisopropylphenol. The drug is prepared in a 5 milliliter syringe and administered intravenously at a slow
Sponsors
Karaj University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 18 to 65 years Informed consent for participation in the study given by the patient and the patient’s legal guardian Physical status I to II according to the American Society of Anesthesiologists (ASA) Blood pressure within the normal range (systolic blood pressure between 90 and 140 mmHg and diastolic blood pressure between 60 and 90 mmHg before induction of anesthesia) Patients with non-psychotic, non-manic, and non-catatonic psychiatric disorders who are diagnosed based on DSM-5 criteria by the treating psychiatrist and are candidates for receiving electroconvulsive therapy (ECT)
Exclusion criteria
Exclusion criteria: Pregnancy and lactation Hypersensitivity or history of allergy to Propofol or Ketamine compounds Patients who are addicts or drug abusers History of cardiovascular and respiratory diseases Use of anticonvulsant medications Lack of cooperation by the patient and the patient’s legal guardian or withdrawal from the study Patients with psychotic, manic, or catatonic psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of induced seizure. Timepoint: Duration of induced seizure during each ECT session, measured from the moment of electric shock induction to the end of observable seizure movements by the assessor. Method of measurement: Time recorded in seconds using a medical stopwatch. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of anesthesia. Timepoint: From the moment of anesthesia administration until the patient reaches an Aldrete score equal to or greater than 9. Method of measurement: Time recorded in minutes using a medical stopwatch.;Changes in systolic and diastolic blood pressure. Timepoint: Before anesthesia administration and five minutes after the end of motor seizure. Method of measurement: Recorded using a vital signs monitor in millimeters of mercury.;Changes in heart rate. Timepoint: Before anesthesia induction, during seizure when the maximum heart rate is recorded from the start of electrical stimulation to the end of observable motor seizure activity, and five minutes after the end of motor seizure. Method of measurement: Recorded using a vital signs monitor in beats per minute.;Observation of common anesthesia-related adverse events, including hemodynamic, respiratory, neurocognitive, and common somatic symptoms (headache, nausea, and restlessness). Timepoint: During the recovery period and up to two hours after the patient reaches an Aldrete score =9. Method of measurement: Recorded using an adverse events checklist by the investigator or through the patient self report form as presence or absence of each symptom.;Use of Atropine. Timepoint: At the occurrence of hemodynamic disturbance or bradycardia. Method of measurement: Recorded in the data collection form as used or not used. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNegar Bahri
Karaj University of Medical Sciences
Outcome results
None listed