Awake intubation requires an anesthetic management that provides sufficient patient safety and comfort, adequate intubating conditions, and stable hemodynamics. In this prospective clinical study, our aim was to determine the median effective dose (ED(50)) of remifentanil in combination with midazolam and airway topical anesthesia for awake laryngoscopy and intubation.Thirty-six female adult patients, scheduled for elective plastic surgery under general anesthesia requiring orotracheal intubation were included in this study. Ten minutes after intravenous administration of midazolam 0.1 mg/kg, patients were assigned to receive remifentanil in bolus, followed by a continuous infusion. The bolus dose and infusion rate of remifentanil were adjusted by a modified Dixon's up-and-down method. Patient's reaction score at laryngoscopy and an Observer's Assessment of Alertness/Sedation Scale (OAA/S) were used to determine whether the remifentanil dosage regimen was accepted. During laryngoscopy, 2% lidocaine was sprayed into the airway to provide the topical anesthesia. ED(50) of remifentanil was calculated by the modified Dixon up-and-down method, and the probit analysis was then used to confirm the results obtained from the modified Dixon's up-and-down method. In the patients who were scored as "accept", patient's OAA/S and reaction scores at different observed points, intubating condition score and patient's tolerance to the endotracheal tube after intubation were evaluated and recorded. Blood pressure and heart rate at different measuring points were also noted.ED(50) of remifentanil for awake laryngoscopy and intubation obtained by the modified Dixon's up-and-down method was (0.62 +/- 0.02) microg/kg. Using probit analysis, ED(50) and ED(95) of remifentanil were 0.63 microg/kg (95% CI, 0.54 - 0.70) and 0.83 microg/kg (95% CI, 0.73 - 2.59), respectively. Nineteen patients who were scored as "accept" had an OAA/S of > 15 and tolerated well laryngoscopy without significant discomfort or gagging. The mean intubating condition score was 1.8 +/- 0.8. The endotracheal tube was well tolerated. During awake laryngoscopy and intubation, blood pressure and heart rate were also kept stable. The postoperative follow up showed that no patient recalled discomfort and pain for airway manipulation.When combined with midazolam 0.1 mg/kg and airway topical anesthesia, ED(50) of remifentanil for successful awake laryngoscopy and intubation is 0.62 microg/kg in bolus followed by continuous infusion of 0.062 microg*kg(-1)*min(-1). This sedation and analgesia regimen can provide patient safety and comfort, ensure adequate intubating conditions, maintain hemodynamic stability, and prevent negative recall of the airway procedure.