A comparative study of the effects of ketamine with midazolam on reducing suicidal ideation in suicide attempters undergoing intubation treatment

Determining the frequency distribution of suicidal thoughts in ketamine recipients and comparing it with midazolam recipients in suicide attempters undergoing intubation treatment

The Clinical trial with control and intervention group, double-blind, randomized, on 42 patients, Permuted block randomization will be used.

The study will be conducted in the psychiatric clinic of Khorshid Hospital. Referrals will be placed into two intervention and control groups using a block randomization method. The intervention group will be given ketamine and the control group will be given midazolam. The psychiatrist and the patient will not be aware of the type of medication given to each referral, and only the statistician will be aware.

Inclusion criteria: All patients between 18 and 65 years of age who have been admitted to the Intensive Care Unit of Khorshid Hospital due to suicide, consent from the guardian or legal supervisor. Exclusion criteria: ECG with extensive abnormal changes, history of ketamine abuse or dependence

Intervention group: Intubated suicide attempters will receive intravenous racemic ketamine hydrochloride from Exir Company at a dose of 0.5 mg/kg in 100 cc of normal saline, infused over 45 minutes. Control group: Intubated suicide attempters will receive intravenous midazolam from Exir Company at a dose of 0.3 to 0.5 mg/kg in 100 cc of normal saline, infused over 40 minutes.

Suicidal ideation score on the Beck-21 Suicidal Ideation Questionnaire scale

Sampling method: Patients are selected consecutively. The first two people who meet the conditions for entering the sample are selected and form a block, and these blocks continue until the sample size is reached. (We will conduct a trial for both people in the manner that will be mentioned and record all the steps and results of the questionnaire, so the purpose of reaching the sample size is not in one day but in a period of time that depends on the number of clients and hospitalized patients.) Within these blocks, people are randomly assigned to either the first intervention or the second intervention, which is done using a random number table. If the number is from 0 to 4, the first person receives the first drug, and otherwise (5-9) the second person. These people are sorted within the block by national code and become the first and second patients. (The larger 10-digit number is the first patient and the smaller number is the second patient).

The two study medications, which were randomly assigned to the patients forming each block using a random number table, are placed in fully sealed envelopes. The participant number in the study (from 1 to 42), corresponding to the medication, is written on the envelope. An experienced nurse who is not a member of the study team, and therefore has no conflict of interest, is selected and instructed to prepare the medication for injection in a separate room out of sight of the researchers and study participants. (Since the nurse administering the injection is not a member of the study team, the name or code of the medication is written on the envelope for the nurse’s information). Since the patient is under anesthesia and unaware of the medication they receive, and the study investigator (a psychiatrist who is the primary designer of the research question and potentially exposed to conflicts of interest) is also unaware of which medication each patient receives, blinding has been implemented. Blinding was not applied to the person responsible for data collection, the outcome assessor, and the statistical consultant. It is noteworthy that informed consent was obtained from the patient’s guardian or legal supervisor prior to participation, and after the patient regains consciousness, they will be informed about their participation in the study—though they will not be informed of the specific medication they received.