Comparison of the effectiveness of hydrocortisone and placebo (distilled water) on hemodynamic changes in atracurium for intubation in patients with upper limb fractures (candidate for elective surgery)

Determination of the effect of hydrocortisone on hemodynamic changes including arterial blood pressure and heart rate resulting from the neuromuscular relaxant atracurium

A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 3 on 48 patients. G * Power software was used for randomization.

The present study will be a double-blind randomized clinical trial (patient and outcome assessor) performed on individuals aged 15 to 60 years to determine the effects of hydrocortisone on hemodynamic changes induced by atracurium for intubation in patients under general anesthesia referred to 5 Azarshahr Medical Center. Gorgan will be done in 2022.

Inclusion criteria: All patients for elective upper limb fracture surgery between the ages of 15-60 with ASA I or II, Exclusion criteria: neuromuscular disorders, receiving antibiotics including aminoglycosides 24 hours before surgery, liver disease And kidney, diabetes, heart failure, allergy to corticosteroids, obesity, taking H1 histamine blocker one day before surgery, lactating and pregnant mothers, psychotic disorders,hypothyroidism,Osteoporosis

Intervention group: 100 mg Jaber hydrocortisone vial with the generic name: Hydrocortisone-Systemic (manufacturer of Jaber Bin Hayan Pharmacy [Iran]) once, 30 minutes before entering the operating room (in the ward) intravenously and bolus with 300 ml They receive normal saline under the supervision of a nurse who has no knowledge of the study groups. Control group: Individuals in the placebo group received the same amount of distilled water with 300 ml of normal saline under the supervision of a nurse who is unaware of the drug groups.

Hemodynamic changes Bronchospasm Number of breaths

Participants in the study were assigned to the intervention (B) and control (A) groups by block randomization. Using a dice that has 6 sides, the samples are assigned to their groups. A number is written on each side and each number is assigned to one of the blocks in the table, which has its own special mode. it shows. Group A (hydrocortisone) and B (placebo of distilled water). A complete list of randomized blocks was provided to the lead researcher by the study epidemiologist.

Blinding in this study is double-blind. After obtaining the consent of the participants, they are blind to their study groups and the preparation and dilution of the drug, which are similar in appearance (size, shape, volume of the manufacturer) is done by the nurse in charge of the department. Minutes before entering the operating room (in the ward), people in the hydrocortisone group receive 100 mg of hydrocortisone intravenously and bolus with 300 ml of normal saline. The doctor in charge of the plan and the intervener will not know the type of drug group. Anesthesia induction will be performed by the project resident resident who has no role in the study outcome process.