Investigating the effect of midazolam on the incidence of restlessness and agitation in patients undergoing electroshock therapy at 5 Azar Hospital in Gorgan in 2023

Determining the effect of midazolam administration on the incidence of restlessness and agitation in patients immediately and one hour after electroshock therapy.

A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 100 patients. For randomization, a list of random numbers was used from the Randomization.com website.

Psychiatry Department of 5 Azar Medical Education Center in Gorgan City.

- The consent of the patient or his legal guardian The patient diagnosed with psychosis is indicated for Electroconvulsive therapy (ECT) - Age range 18-75 years - Patient's satisfaction to conduct research Exclusion Criteria: - Allergy to any of the anesthetic drugs - Creating hemodynamic changes or less than 20 requiring intervention - The need for more anesthetic drugs for patient induction - Having a history of malignant hyperthermia and a family history -Suffering from cardiovascular diseases without compensation - Known cases of chronic respiratory disease - Clear history of liver and kidney disease - History of Myocardial infarction (MI) less than 6 months - Presence of high intracranial pressure (ICP) - Having a brain tumor - Known cases of cerebrovascular problems (such as aneurysm)

This study group has the same entry characteristics as the control group, with the difference that in order to perform electroshock therapy, midazolam is administered at the rate of 0.02-0.01 mg/kg in 3-4 minutes before intravenous atropine injection to the patient. It is injected and, like the control group, 2 mg/kg of nesdonal and 0.5 mg/kg of succinylcholine are used for induction and relaxation. The only difference between these two groups is the intravenous injection of midazolam.

Agitation and restlessness

By referring to the Randomization.com website and using the block of four method, a list of random numbers will be generated by a member of the research team, who is the only one who knows about the process of entering the groups (sample size of 50 people, in two Group A – B). Then the letters A-B will be written on the cards and placed in thick numbered envelopes (1 to 50). After checking the entry criteria, the participating people will receive the respective envelopes in the order of entry into the study and their allocation status will be determined into two groups of intervention (A) and comparison (B) according to the cards in the envelopes. It is obvious that the sequence of entering the groups will be kept secret until the start of the intervention.

At first, two separate groups are considered group A (midazolam group) and group B (placebo). Groups A and B are randomly selected for each person and every visit for electroshock therapy by the anesthesiologist (who is aware of the drug content). It is not group A or B) and is injected by him. In this case, each person may randomly receive midazolam in four times of his injection, for example, he may be in group A (or he may not receive it) or group B. It should be said that the number of questionnaires A and B and the prepared drugs are equal. Neither the anesthesiologist, nor the attending resident, nor the anesthetist, nor the two attending nurses know about the content of midazolam or distilled water. Only an anesthesiologist who prepares the drugs from the operating room He is aware of the drugs and delivers the drugs to the electroshock therapy environment and leaves the environment.