PURPOSE: The aim of this study was to evaluate the clinical efficacy and safety of patient-controlled remifentanil application in combination with intravenous (IV) midazolam sedation during third molar surgery. PATIENTS AND METHODS: Twenty healthy patients with symmetrically placed impacted bilateral mandibular third molars were included in this prospective, placebo-controlled, double-blind, cross-over, randomized clinical study. A bolus dose of 0.05 mg/kg intravenous midazolam was applied to each patient. Remifentanil was administered (group MR) by patient controlled infusion (PCI) either in the first or the second operation. In the other operation, a placebo (group MP) was given in the same manner. Perioperative blood samples were obtained to determine the changes in the stress hormone (aldosterone, adrenocorticotropic hormone [ACTH], renin) levels. Vital signs and oxygen saturation were recorded. Ramsey's sedation scale and modified Steward's recovery scale was used for evaluation of consciousness. Pain, patient satisfaction, cooperation score, reaction to local anesthetic injection, and degree of amnesia were also assessed. RESULTS:Remifentanil significantly increased the level of sedation, patient cooperation, and satisfaction; decreased the oxygen saturation, heart rate, and pain. While renin levels were significantly different, ACTH and aldosteron levels did not differ significantly between the 2 groups. Aldosterone and ACTH levels significantly decreased, whereas the renin level significantly increased in both groups during the operations. Remifentanil did not significantly alter the recovery time. CONCLUSION:Patient-controlled remifentanil application in combination with IV midazolam sedation seems to be a safe and reliable method, which effectively eliminates pain and provides a satisfactory sedation level, without any serious side effect.
RCT Entities:
PURPOSE: The aim of this study was to evaluate the clinical efficacy and safety of patient-controlled remifentanil application in combination with intravenous (IV) midazolam sedation during third molar surgery. PATIENTS AND METHODS: Twenty healthy patients with symmetrically placed impacted bilateral mandibular third molars were included in this prospective, placebo-controlled, double-blind, cross-over, randomized clinical study. A bolus dose of 0.05 mg/kg intravenous midazolam was applied to each patient. Remifentanil was administered (group MR) by patient controlled infusion (PCI) either in the first or the second operation. In the other operation, a placebo (group MP) was given in the same manner. Perioperative blood samples were obtained to determine the changes in the stress hormone (aldosterone, adrenocorticotropic hormone [ACTH], renin) levels. Vital signs and oxygen saturation were recorded. Ramsey's sedation scale and modified Steward's recovery scale was used for evaluation of consciousness. Pain, patient satisfaction, cooperation score, reaction to local anesthetic injection, and degree of amnesia were also assessed. RESULTS:Remifentanil significantly increased the level of sedation, patient cooperation, and satisfaction; decreased the oxygen saturation, heart rate, and pain. While renin levels were significantly different, ACTH and aldosteron levels did not differ significantly between the 2 groups. Aldosterone and ACTH levels significantly decreased, whereas the renin level significantly increased in both groups during the operations. Remifentanil did not significantly alter the recovery time. CONCLUSION:Patient-controlled remifentanil application in combination with IV midazolam sedation seems to be a safe and reliable method, which effectively eliminates pain and provides a satisfactory sedation level, without any serious side effect.