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IRCT20170108031818N3 IRCT 2023-01-23 Gorgan University of Medical Sciences The effect of midazolam drug on the occurrence of restlessness and agitation in patients undergoing electroshock therapy 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 2023-02-20 anticipated 100 Complete https://irct.ir/trial/67804 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Patients undergoing electroshock therapy. Intervention 1: For the intervention group, before the induction of anesthesia, hemodynamic symptoms are measured before anesthesia, and the patient is preoxygenated. Then midazolam drug at the rate of 0.01-0.02 mg/kg in 3 to 4 minutes before intravenous atropine injection. It is injected into the patient to prevent the parasympathetic side effects caused by the electric shock, then 2 mg per Kg of nesdonal is used for induction of anesthesia, and 0.5 mg/kg of succinylcholine is used to create muscle relaxation. Then the electric shock is performed by a neurologist. During the electric shock, a sponge Y piece is used in the patient's mouth to protect the patient's airway during tonic and clonic convulsions and to protect the patient's teeth from stiffness caused by Do not break the contraction. After the convulsions end, the patient is suctioned through the mouth and oxygen therapy is performed so that the patient returns to spontaneous breathing. Intervention 2: Control group: the anesthesiologist preoxygenates the patient before the induction of anesthesia and injects two cc of distilled water from a syringe without knowing the contents of the syringe, then 3 to 4 minutes later, 0.5 mg of atropine is administered intravenously. to prevent the parasympathetic side effects caused by the electric shock, then 2 mg/kg of nesdonal is used for induction of anesthesia and 0.5 mg/kg of succinylcholine is used to induce muscle relaxation, then the electric shock is administered by a neurologist. It is done, during the electric shock in the patient's mouth, the Y sponge piece is used to protect the patient's airway during the tonic and clonic convulsions and prevent the patient's teeth from breaking due to the stiffness caused by the contraction. After the convulsions end. , the patient is suctioned through the mouth and oxygen therapy is performed so that the patient returns to spontaneous breathing.". Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Still undecided - no release schedule yet
public Dr. Seyed Maherukh Madah
Shasat Kala Street
Gorgan Iran (Islamic Republic of) 4915789465 +98 17 3217 7419 mehravar10261@yahoo.com Gorgan University of Medical Sciences scientific Dr. Seyed Maherukh Madah
Shasat Kala Street
Gorgan Iran (Islamic Republic of) 4915789465 +98 17 3217 7419 mehravar10261@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) The patient diagnosed with psychosis is indicated for ECT 18 years 75 years Both Age range 18-75 years Patient satisfaction to conduct research Treatment - Drugs Treatment - Drugs For the intervention group, before the induction of anesthesia, hemodynamic symptoms are measured before anesthesia, and the patient is preoxygenated. Then midazolam drug at the rate of 0.01-0.02 mg/kg in 3 to 4 minutes before intravenous atropine injection. It is injected into the patient to prevent the parasympathetic side effects caused by the electric shock, then 2 mg per Kg of nesdonal is used for induction of anesthesia, and 0.5 mg/kg of succinylcholine is used to create muscle relaxation. Then the electric shock is performed by a neurologist. During the electric shock, a sponge Y piece is used in the patient's mouth to protect the patient's airway during tonic and clonic convulsions and to protect the patient's teeth from stiffness caused by Do not break the contraction. After the convulsions end, the patient is suctioned through the mouth and oxygen therapy is performed so that the patient returns to spontaneous breathing. Control group: the anesthesiologist preoxygenates the patient before the induction of anesthesia and injects two cc of distilled water from a syringe without knowing the contents of the syringe, then 3 to 4 minutes later, 0.5 mg of atropine is administered intravenously. to prevent the parasympathetic side effects caused by the electric shock, then 2 mg/kg of nesdonal is used for induction of anesthesia and 0.5 mg/kg of succinylcholine is used to induce muscle relaxation, then the electric shock is administered by a neurologist. It is done, during the electric shock in the patient's mouth, the Y sponge piece is used to protect the patient's airway during the tonic and clonic convulsions and prevent the patient's teeth from breaking due to the stiffness caused by the contraction. After the convulsions end. , the patient is suctioned through the mouth and oxygen therapy is performed so that the patient returns to spontaneous breathing." Restlessness and agitation. Timepoint: Twice a day at 8-10 and 16-18 for a maximum of 4 days. Method of measurement: The Richmond Agitation and Sedation Scale (RASS). Cardiovascular response of trauma patients in special surgery departments. Timepoint: Before and after each drug intervention. Method of measurement: Blood pressure with a blood pressure monitor device and the patient's pulse with a heart and breathing monitor with a manual counter in one minute. Gorgan University of Medical Sciences Approved 2022-12-11 Ethics committee of Golestan University of Medical Sciences Shasat Kala Street Gorgan Golestan Iran (Islamic Republic of)