Comparative study of hemodynamic changes, amount of bleeding, satisfaction of surgeon and patient in the use of two drugs, Midazolam and Dexmedetomedin, in laminectomy surgery under spinal anesthesia

Investigation of the effect of Midazolam and Dexmedetomidine injection on the effects of laminectomy under spinal anesthesia

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 105 patients. Simple randomization tables are used for randomization

This study is a randomized double-blind clinical trial with a control group, the target population of which will be candidates for spinal laminectomy under spinal anesthesia at Al-Zahra Medical Center in Isfahan. Patients are distributed in three groups by simple random sampling. After placing on the operating table and performing spinal anesthesia on each group, one of the injected drug interventions, vital signs, and hemodynamic status of the patient before, during, and after surgery are controlled and recorded. Interventional groups are coded, so the injector, clinical caregiver, surgeon, and patient are unaware of the injected intervention and are blind.

Patients between the ages of 18 and 65 who are candidates for laminectomy under spinal anesthesia who are in the ASA class of anesthesia I and II and do not have a specific underlying problem can enter the study.

After the patient is placed on the operating table and connected to standard monitors, the patient undergoes spinal anesthesia. Then, in group A patients, 0.2 mg/kg / h of Midazolam was given, in group B patients, 0.1 μg / kg / h Dexmedetomidine, and in group C patients, 50 cc of normal saline will be infused per hour.

Blood Pressure; Heart Rate; Oxygen Saturation; Bleeding Rate; Surgeon satisfaction; Patient satisfaction

Randomization in this study is simple and using a randomization table so that 105 patients with entry conditions are selected and each is given a three-digit code and these codes are entered in the table and then for each From the intervention groups, we randomly select 35 patients using these codes from the table.

Drugs and placebo are prepared and coded in the same way. The patient, the injecting specialist, the surgeon, and the respondent are unaware of the contents of the injected drug and are blind.