A prospective randomized double-blind study comparing dexmedetomidine vs. combination of midazolam-fentanyl for tympanoplasty surgery under monitored anesthesia care

Abstract

Background:Analgesia and sedation are usually required for the comfort of the patient and surgeon during tympanoplasty surgery done under local anesthesia. In this study, satisfaction scores and effectiveness of sedation and analgesia with dexmedetomidine were compared with a combination of midazolam-fentanyl.Materials and Methods:Ninety patients undergoing tympanoplasty under local anesthesia randomly received either IV dexmedetomidine 1 μg kg-1 over 10 min followed by 0.2 μg kg-1h-1 infusion (Group D) or IV midazolam 0.06 mg kg-1 plus IV fentanyl 1 μg kg-1 over 10 min (Group MF) followed by normal saline infusion at 0.2 ml kg-1h-1. Sedation was titrated to Ramsay sedation score (RSS) of three. Vital parameters, rescue analgesics (fentanyl 1 μg kg-1) and sedatives (midazolam 0.01 mg kg-1), patient and surgeon satisfaction scores were recorded.Results:Patient and surgeon satisfaction score was better in Group D than Group MF (median interquartile range (IQR) 9 (8-10) vs. 8 (6.5-9.5) and 9 (8.5-9.5) vs. 8 (6.75-9.25), P = 0.0001 for both). Intraoperative heart rate and mean arterial pressure in Group D were lower than the baseline values and the corresponding values in Group MF (P < 0.05). Percentage of patients requiring rescue fentanyl was higher in Group MF than Group D (40% vs. 11.1%, P = 0.01). One patient in Group D while four in Group MF (8.8%) required rescue sedation with midazolam (P > 0.17). Seven patients in Group D had dry mouth vs. none in Group MF (P = 0.006). One patient in Group D had bradycardia with hypotension which was effectively treated.Conclusion:Dexmedetomidine is comparable to midazolam-fentanyl for sedation and analgesia in tympanoplasty with better surgeon and patient satisfaction. Hemodynamics need to be closely monitored.

A comparative study of dexmedetomidine vs midazolam for sedation and hemodynamic changes during tympanoplasty and modified radical mastoidectomy

“…Devangi A. Parikh 18 So by summarizing above comparisons we can conclude that for monitored anaesthesia care in ENT surgeries performed under local anaesthesia, intravenous Dexmedetomidine could be a better alternative compared to conventional sedation with Midazolam, since it provides a calm patient with better intraoperative analgesia, and a bloodless surgical field leading to increased satisfaction of both patient and surgeon.…”

Comparison of Hypotension Caused By Dexmedetomidine– Fentanyl Combination with that of Midazolam–Fentanyl Combination in Hypertensive Patients Undergoing Tympanoplasty Surgery under MAC

“…Over sedation leading to respiratory depression is an important complication during MAC. [17,35] In the present study, the doses of dexmedetomidine 1µg/kg, [16,19,20] midazolam 0.06 mg/kg, [16,17,19,20] and fentanyl 2µg/kg, [16,19,20] was chosen based on previous studies. The dose of midazolam 0.06 mg/kg is comparable to that of dexmedetomidine 1µg/kg in term of sedation.…”

“…Commonly, midazolam is given in combination with fentanyl in MAC. [16][17][18][19][20] This combination has the advantage of potentiating both hypotensive and sedative effect. It has minimal effect on heart rate as midazolam causes mild tachycardia and fentanyl causes mild bradycardia.…”

“…This technique is called Monitored Anaesthesia Care (MAC). [12] Medications commonly used for MAC include Ketamine, [13] Propofol, [14,15] Pentazocine, [16] combination of Midazolam-Fentanyl, [16][17][18][19][20] Midazolam as single agent, [21][22][23] Dexmedetomidine as a single agent and combination of Dexmedetomidine-Fentanyl. [20] Combination of Dexmedetomidine with Fentanyl leads to potentiation of all actions of Dexmedetomidine resulting in excellent hypotension, sedation and analgesia during the intraoperative period.…”

Effect of Different Doses of Dexmedetomidine on Stress Response and Emergence Agitation after Laparoscopic Cholecystectomy: Randomized Controlled Double-Blind Study

“…It decreases surgical stress response and leads to better stable hemodynamic properties [9]. Dexmedetomidine decreases the postoperative supplemental analgesic requirements and pain intensity.…”