Double-Blind, Randomized, Controlled Pilot Trial to Specify Collateral Effect and Safety of Perioperative Dexmedetomidine in Patients Undergoing Open Heart Surgery

Abstract

Background: This study aimed to assess the collateral effects and safety of dexmedetomidine (Dex) during and one day after surgery in Iranian patients undergoing open heart surgery, to expand the clinical applications of Dex in Iran. Methods: This pilot study was conducted in Gorgan, Golestan province, Iran, in 2024. Both male and female participants undergoing open heart surgery were randomly assigned to either the Dex group (n = 10), receiving 0.5 µg/kg/h along with standard anesthesia management, or the control group (n = 10). The primary outcome was the percentage of patients experiencing adverse events. Secondary outcomes included the stability of hemodynamic and respiratory parameters, the occurrence of arrhythmias, and biological changes assessed during and 24 hours after surgery. Results: Out of 45 participants, 20 were enrolled and analyzed. The comparison between groups showed that observed adverse effects were higher in the control group (4 patients) compared to the Dex group (1 patient), with common events being hypotension, bradycardia, and tachycardia. Biological markers, such as lactate and blood sugar (BS), increased in both groups, with the control group showing a greater increase in both lactate and BS levels (P = 0.012 and P = 0.009, respectively) compared to the Dex group (P = 0.017 and P = 0.093, respectively). Additionally, there were no significant differences in hemodynamic and respiratory markers between the groups (P > 0.05); however, Dex improved and preserved hemodynamic and respiratory stability more effectively. Conclusions: The addition of Dex to the anesthesia protocol was safe and without adverse events, showing a promising role in improving cardiac function in patients undergoing open heart surgery.