Comparison of Intra and Post-operative Sedation Efficacy of Dexmedetomidinemidazolam and Dexmedetomidine-propofol for Major Abdominal Surgery

Background: The effectiveness and side effects of dexmedetomidine (DEX) in combination with midazolam and propofol have not been comparatively studied in a single clinical trial as sedative agents to general anesthesia before. Objective: The objective of this study is to compare intra and post-operative sedation between DEX-Midazolam and DEX-Propofol in patients who underwent major abdominal surgery on the duration of general anesthesia, hemodynamic and sedation effect. Method: This prospective, randomized, double-blinded clinical trial included 50 patients who were 20 to 60 years of age and admitted for major abdominal surgery. The patients were randomly assigned by a computer-generated random numbers table to sedation with DEX plus midazolam (DM group) (n=25) or DEX plus propofol (DP group) (n=25). In the DM group, patients received a bolus dose of 0.1 mg/kg of midazolam and immediately initiated the intravenous (i.v.) infusion of DEX 1 μg/kg over a 10 min and 0.5 μg/kg/hr by continuous i.v. infusion within operation period. In the DP group, patients received pre-anesthetic i.v. DEX 1 μg/kg over 15 min before anesthesia induction and 0.2-1 μg/kg/hr by continuous i.v. infusion during the operative period. After preoxygenation for at least 2 min, during the surgery, patients received propofol infusion dose of 250 μg/kg/min for 15 min then a basal infusion dose of 50 μg/kg/min. The bispectral index (BIS) value, as well as mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SaO2), percutaneous arterial oxygen saturation (SpO2) and end-tidal carbon dioxide tension (ETCO2) were recorded before anesthesia (T0), during anesthesia (at 15-min intervals throughout the surgical procedure), by a blinded observer. Evidence of apnea, hypotension, hypertension and hypoxemia were recorded during surgery. Results: The hemodynamic changes, including HR, MAP, BIS, VT, SaO2, and RR had a downward tendency with time, but no significant difference was observed between the groups (P>0.05). However, the two groups showed no significant differences in ETCO2 and SPO2 values in any of the assessed interval (P>0.05). In this study, the two groups showed no significant differences in the incidence of nausea, vomiting, coughing, apnea, hypotension, hypertension, bradycardia and hypoxemia (P>0.05). Respiratory depression and serious adverse events were not reported in either group. Extubation time after surgery was respectively 6.3 ± 1.7 and 5.8 ± 1.4 hr. in the DM and DP groups and the difference was not statistically significant (P= 0.46). Conclusion: Our study showed no significant differences between the groups in hemodynamic and respiratory changes in each of the time intervals. There were also no significant differences between the two groups in the incidence of complication intra and post-operative. Further investigations are required to specify the optimum doses of using drugs which provide safety in cardiovascular and respiratory system without adverse disturbance during surgery. Clinical Trial Registration Number: HTCY-MA2018-74.