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Study aim
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Determining the effect of propofol with or without ketamine on the result of the Montreal test in patients with mood disorders treated with electroshock in Imam Hossein (AS) hospital in 1402
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Design
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Clinical trial with a control group, with parallel groups, double-blind, randomized, phase one on 88 patients. In both groups, the day before the ECT treatment, one day after the end of the ECT treatment, and one month after the last ECT treatment session, the Montreal cognitive test will be performed, and the effect of ketamine will be compared on cognition
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Settings and conduct
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The study population is selected from the Imam Hossein Hospital, diagnosed with any type of mood disorders (unipolar, bipolar, with or without psychosis, and major depressive disorder) based on DSM-5 criteria and identified by a psychiatrist as requiring ECT treatment. After obtaining informed consent, the patients will undergo a comprehensive psychiatric evaluation and physical examination by a psychiatry resident. Patients meeting the inclusion and exclusion criteria will be enrolled in the study. Allocation concealment will be accomplished by placing cards inside opaque, sealed, and sequentially numbered envelopes (Sequence Numbered Sealed Opaque Envelopes - SNOSE)
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Participants/Inclusion and exclusion criteria
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Persian-speaking 18-70 year old patients diagnosed with mood disorders (bipolar I or II, with/without psychosis, major depression) requiring ECT treatment, with no neurological/cognitive diseases or alcohol use in the past 14 days or opioid/amphetamine use in the past month.
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Intervention groups
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the intervention group, induction of general anesthesia will be performed using Pofol injection and simultaneous injection of intravenous ketamine hydrochloride, and in the control group, induction of general anesthesia will be performed using only Pofol.
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Main outcome variables
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Pre and post(1 month after)ECT montreal test