Evaluation of the effect of different doses of remifentanil intranasal on hemodynamic changes induced by electroconvulsive therapy

Determination and comparison of the effect of different doses of remifentanil intranasal on hemodynamic changes induced by electroconvulsive therapy

Randomized, Controlled, Single-blinding clinical trial, with the parallel groups, Phase 3 on 80 patients

Eighty patients who are candidates for electroconvulsive therapy presented at Khorshid Hospital in Isfahan will be included and randomly divided into four groups. The 3 groups will receive 0.25, 0.50, and 0.75 mg/kg of remifentanil respectively and the control group will receive a placebo. The specialist and the patient will not be aware of the type of intervention group.

Inclusion criteria: The patients aged over 18 years old; candidates for electroconvulsive therapy for the first time; classified as ASA I; no fever, and consent to participate in the study are included. Non inclusion criteria: allergy to remifentanil; history of nasal diseases that interfere with the intranasal administration of the drug.

Intervention group 1: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.25 mg/kg intranasally in both nostrils. Intervention group 2: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.5 mg/kg intranasally in both nostrils Intervention group 3: Prior to electroconvulsive therapy, patients receive remifentanil at a dose of 0.75 mg/kg intranasally in both nostrils. Control group: Prior to electroconvulsive therapy, patients receive a placebo intranasally in both nostrils. In all groups,1 minute after the intervention, anesthetic induction drugs including midazolam, thiopental sodium, and succinylcholine were injected based on the patients' weight. Patients receive electroconvulsive therapy 30 to 45 seconds after receiving succinylcholine.

Blood pressure; Heart rate; Oxygen saturation; Duration of convulsion

80 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.

In order to achieve the double-blind study, different doses of remifentanil and placebo (without remifentanil) will be prepared daily by the nurse of the electroshock ward (without the researcher's awareness) and placed in the bag and will be labeled A, B, C and D. And is given daily to the anesthesiologist (researcher). Therefore, the patient will not be aware of the type of medicine he/she is receiving.

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