title: A Randomized, Double-blind, Non-inferiority Trial of Magnesium Sulphate versus Dexamethasone for Prevention of Postoperative Sore Throat after Lumbar Spinal Surgery in the Prone Position.
abstract: BACKGROUND
  Postoperative sore throat (POST) is a frequent complication of tracheal intubation, particularly after surgery in the prone position. We designed this study to validate the non-inferiority of magnesium sulphate against dexamethasone for prevention of POST after lumbar spinal surgery.
  
  
  METHODS
  One hundred and forty-six patients were randomly allocated to receive either magnesium or dexamethasone. Before anesthetic induction, the magnesium group (n = 73) received magnesium sulphate 30 mg/kg followed by 10 mg/kg/h by continuous infusion until the end of surgery. The dexamethasone group (n = 73) received dexamethasone 8 mg. The primary endpoint was the overall incidence of POST, which was assessed serially over 48 hr postoperatively. The predefined margin of non-inferiority for magnesium against dexamethasone was 15%.
  
  
  RESULTS
  Overall incidences of POST at rest (50.7% versus 49.3% in the magnesium and dexamethasone group, respectively, p = 0.869) and swallowing (65.8% versus 61.6% in the magnesium and dexamethasone group, respectively, p = 0.606) were not different between the groups. The upper limit of the 90% confidence interval, which must be lower than the predefined margin of non-inferiority to prove the non-inferiority of magnesium sulphate against dexamethasone, for at rest and swallowing were 14.97% (p = 0.0496) and 17.19% (p = 0.0854), respectively. The incidences and severities of POST and hoarseness were also not different between the groups throughout the study period.
  
  
  CONCLUSIONS
  Prophylactic magnesium sulphate appears to be non-inferior to dexamethasone for the prevention of POST at rest in patients undergoing lumbar spinal surgery in the prone position.
authors.affiliation: 1. Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine.
authors.forename: Jin Ha
authors.initials: JH
authors.lastname: Park
authors.affiliation: 2. Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jae-Kwang
authors.initials: JK
authors.lastname: Shim
authors.affiliation: 2. Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Jong-Wook
authors.initials: JW
authors.lastname: Song
authors.affiliation: 1. Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine.
authors.forename: Jaewon
authors.initials: J
authors.lastname: Jang
authors.affiliation: 1. Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine.
authors.forename: Ji Hoon
authors.initials: JH
authors.lastname: Kim
authors.affiliation: 2. Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Young-Lan
authors.initials: YL
authors.lastname: Kwak
mesh_terms: D000328:Adult; D000368:Aged; D003907:Dexamethasone / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae / Q000601:surgery*; D008278:Magnesium Sulfate / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010612:Pharyngitis / Q000453:epidemiology / Q000517:prevention & control*; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D016684:Prone Position; D011446:Prospective Studies
chemical_list: D008278:Magnesium Sulfate; D003907:Dexamethasone
keywords: Dexamethasone; Magnesium; Postoperative sore throat; Prone position