Comparison of efficacy and safety of two muscle relaxants cisatracurium and succinylcholine in Electroconvulsive therapy; A randomized, single-blind clinical trial study

Comparing the efficacy and safety of two muscle relaxants, cisatracurium and succinylcholine in electroconvulsive therapy

A single-blinded and randomized clinical trial, phase 3, without control group, with parallel groups design of 62 patients

This study will be done as a clinical trial at Shafa hospital in Rasht. Informed consent will be taken from patients and if not possible to communicate, it will be obtained from the patient's legal companion. The procedure is the same for both groups. A fasting period of eight hours will be observed for all patients. Standard monitoring will be performed upon the patient's arrival at the ECT ward. After establishing a suitable intravenous line, induction of anesthesia will be done. After confirming proper ventilation with mask and no response to verbal commands, relaxing drugs will be injected and the patient will get electroshock therapy.According to returning of spontaneous breathing and level of consciousness, the patient will be monitored for 15 to 20 minutes in the recovery department and then discharged. In this study, only the patient is blind, and the evaluator (resident of anesthesiology) and the responsible anesthesiologist are aware of the groups.

Inclusion criteria: Patients 18 years and older, ASA I, II, Normal body mass index, No criteria for difficult mask ventilation, No contraindication for cisatracurium and succinylcholine.Exclusion criteria: myasthenia gravis, History of malignant hyperthermia, History of burns, Kidney failure, Guillain-Barré syndrome, Dangerous arrhythmias.

First group: induction of anesthesia with Propofol 1 mg per kg and succinylcholine 0.5 mg per kg.Second group: Propofol 1 mg per kg and Cis atracurium 0.1 mg per kg are prescribed.

Seizure duration, time of returning of the effective breaths of the patient time of recovery

Patients will be divided into two groups by an anesthesia technician who does not participate in the project, using four random blocks created by the computer (Win Pepi 11.65 software). This is done through a list of eligible patients who have given informed consent. They will be assigned to one of the two groups receiving succinylcholine or cisatracurium by a sequence of randomization blocks in a 1: 1 ratio. The output of the software consists of letters and numbers. The letters A and B indicate the under-study treatments (succinylcholine and cisatracurium) and the indicated numbers indicate the patients who will be assigned to the treatments consecutively.

This study is a single-blinded study. In this way, the patient is blind, but due to the nature of the relaxant drugs and their different pharmacodynamics, including obvious and generalized fasciculation of succinylcholine, the evaluator (resident of anesthesiology) who fills out the checklist is aware of the treatment groups. The responsible anesthesiologist present in the shock department is also aware of the groups in order to perform the necessary intervention in case of complications (bradycardia, master spasm, ECG changes in favor of hyperkalemia, hemodynamic changes, and arterial blood oxygenation).