A prospective randomized controlled double-blind trial to assess the effects of dexmedetomidine during cleft palate surgery

BACKGROUND: We investigated whether the intraoperative administration of dexmedetomidine would attenuate the profound sympathoadrenal response associated with cleft palate (CP) surgery. METHODS: Sixty children aged 6 months to 12 years undergoing CP surgery under general anesthesia were randomly assigned to the control (C) or dexmedetomidine (D) groups. Group C received benzodiazepine (0.05 mg/kg midazolam followed by infusion of normal saline) fentanyl isoflurane anesthesia, and Group D received dexmedetomidine (loading 1 µg/kg followed by infusion of 0.5 µg/kg/h) fentanyl isoflurane anesthesia. Heart rate (HR), mean blood pressure (MBP), intraoperative fentanyl and isoflurane requirements, recovery scores, emergence agitation, pain scores, time and requirement of rescue analgesic, and surgeon satisfaction were noted. RESULTS: Intraoperative HR and MBP in Group D were significantly lower than the corresponding values in Group C (P < 0.001). HR decreased up to 16% in Group D. By contrast, HR increased up to 20% in Group C. Group D had comparable MBP to its baseline, whereas Group C had higher MBP until extubation (P = 0.015). Two children in Group D developed bradycardia and hypotension, which was successfully treated. The fentanyl and isoflurane requirements decreased by 43% and 30%, respectively, in Group D patients compared to those in Group C (P < 0.001). Group D had lower pain scores and less emergence agitation (P < 0.001). Time until requirement of first rescue analgesic was longer in Group D than that in Group C (P < 0.001). Surgeon satisfaction was higher in Group D than that in Group C. CONCLUSIONS: Intravenous dexmedetomidine during CP surgery attenuated hemodynamic responses with excellent surgeon satisfaction. Close monitoring of hemodynamics is recommended.