title: Low-Dose or High-Dose Rocuronium Reversed with Neostigmine or Sugammadex for Cesarean Delivery Anesthesia: A Randomized Controlled Noninferiority Trial of Time to Tracheal Intubation and Extubation.
abstract: BACKGROUND
  Rocuronium for cesarean delivery under general anesthesia is an alternative to succinylcholine for rapid-sequence induction of anesthesia because of the availability of sugammadex for reversal of neuromuscular blockade. However, there are no large well-controlled studies in women undergoing general anesthesia for cesarean delivery. The aim of this noninferiority trial was to determine whether rocuronium and sugammadex confer benefit in time to tracheal intubation (primary outcome) and other neuromuscular blockade outcomes compared with succinylcholine, rocuronium, and neostigmine in women undergoing general anesthesia for cesarean delivery.
  
  
  METHODS
  We aimed to enroll all women undergoing general anesthesia for cesarean delivery in the 2 participating university hospitals (Brno, Olomouc, Czech Republic) in this single-blinded, randomized, controlled study. Women were randomly assigned to the ROC group (muscle relaxation induced with rocuronium 1 mg/kg and reversed with sugammadex 2-4 mg/kg) or the SUX group (succinylcholine 1 mg/kg for induction, rocuronium 0.3 mg/kg for maintenance, and neostigmine 0.03 mg/kg for reversal of the neuromuscular blockade). The interval from the end of propofol administration to tracheal intubation was the primary end point with a noninferiority margin of 20 seconds. We recorded intubating conditions (modified Viby-Mogensen score), neonatal outcome (Apgar score <7; umbilical artery pH), anesthesia complications, and subjective patient complaints 24 hours after surgery.
  
  
  RESULTS
  We enrolled 240 parturients. The mean time to tracheal intubation was 2.9 seconds longer in the ROC group (95% confidence interval, -5.3 to 11.2 seconds), noninferior compared with the SUX group. Absence of laryngoscopy resistance was greater in the ROC than in the SUX groups (ROC, 87.5%; SUX, 74.2%; P = 0.019), but there were no differences in vocal cord position (P = 0.45) or intubation response (P = 0.31) between groups. No statistically significant differences in incidence of anesthesia complications or in neonatal outcome were found (10-minute Apgar score <7, P = 0.07; umbilical artery pH, P = 0.43). The incidence of postpartum myalgia was greater in the SUX group (ROC 0%; SUX 6.7%; P = 0.007). The incidence of subjective complaints was lower in the ROC group (ROC, 21.4%; SUX, 37.5%; P = 0.007).
  
  
  CONCLUSIONS
  We conclude that rocuronium for rapid-sequence induction is noninferior for time to tracheal intubation and is accompanied by more frequent absence of laryngoscopy resistance and lower incidence of myalgia in comparison with succinylcholine for cesarean delivery under general anesthesia.
authors.affiliation: From the *Department of Pediatric Anesthesiology and Intensive Care Medicine, University Hospital Brno, Faculty of Medicine, Masaryk University, Brno, Czech Republic; †Department of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc, and Faculty of Medicine and Dentistry, Palacky University Olomouc, Olomouc, Czech Republic; ‡2nd Anesthesiological Department, University Hospital Brno, Brno, Czech Republic; §Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czech Republic; ‖Department of Obstetrics and Gynecology, University Hospital Brno, Faculty of Medicine, Masaryk University, Brno, Czech Republic; ¶Department of Anesthesiology and Intensive Care Medicine, University Hospital Brno, Faculty of Medicine, Masaryk University, Brno, Czech Republic; #Department of Obstetrics and Gynecology, University Hospital Olomouc, and Faculty of Medicine and Dentistry, Palacky University Olomouc, Olomouc, Czech Republic; and **Department of Anesthesiology and Intensive Care Medicine, University Hospital Ostrava, and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Stourac
authors.forename: Milan
authors.initials: M
authors.lastname: Adamus
authors.forename: Dagmar
authors.initials: D
authors.lastname: Seidlova
authors.forename: Tomas
authors.initials: T
authors.lastname: Pavlik
authors.forename: Petr
authors.initials: P
authors.lastname: Janku
authors.forename: Ivo
authors.initials: I
authors.lastname: Krikava
authors.forename: Zdenek
authors.initials: Z
authors.lastname: Mrozek
authors.forename: Martin
authors.initials: M
authors.lastname: Prochazka
authors.forename: Jozef
authors.initials: J
authors.lastname: Klucka
authors.forename: Roman
authors.initials: R
authors.lastname: Stoudek
authors.forename: Ivana
authors.initials: I
authors.lastname: Bartikova
authors.forename: Martina
authors.initials: M
authors.lastname: Kosinova
authors.forename: Hana
authors.initials: H
authors.lastname: Harazim
authors.forename: Hana
authors.initials: H
authors.lastname: Robotkova
authors.forename: Karel
authors.initials: K
authors.lastname: Hejduk
authors.forename: Zuzana
authors.initials: Z
authors.lastname: Hodicka
authors.forename: Martina
authors.initials: M
authors.lastname: Kirchnerova
authors.forename: Jana
authors.initials: J
authors.lastname: Francakova
authors.forename: Lenka
authors.initials: L
authors.lastname: Obare Pyszkova
authors.forename: Jarmila
authors.initials: J
authors.lastname: Hlozkova
authors.forename: Pavel
authors.initials: P
authors.lastname: Sevcik
mesh_terms: D000293:Adolescent; D000328:Adult; D000732:Androstanols / Q000008:administration & dosage* / Q000009:adverse effects; D000768:Anesthesia, General / Q000009:adverse effects; D000773:Anesthesia, Obstetrical / Q000009:adverse effects / Q000379:methods*; D000931:Antidotes / Q000008:administration & dosage* / Q000009:adverse effects; D002585:Cesarean Section / Q000009:adverse effects; D002800:Cholinesterase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D018153:Czech Republic; D005260:Female; D006801:Humans; D007442:Intubation, Intratracheal; D007828:Laryngoscopy; D008875:Middle Aged; D063806:Myalgia / Q000209:etiology / Q000517:prevention & control; D009388:Neostigmine / Q000008:administration & dosage* / Q000009:adverse effects; D019148:Neuromuscular Blockade / Q000009:adverse effects / Q000379:methods*; D003473:Neuromuscular Nondepolarizing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D010149:Postoperative Pain / Q000209:etiology / Q000517:prevention & control; D011247:Pregnancy; D000077123:Rocuronium; D016037:Single-Blind Method; D013390:Succinylcholine / Q000008:administration & dosage; D000077122:Sugammadex; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult; D047408:gamma-Cyclodextrins / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000732:Androstanols; D000931:Antidotes; D002800:Cholinesterase Inhibitors; D003473:Neuromuscular Nondepolarizing Agents; D047408:gamma-Cyclodextrins; D000077122:Sugammadex; D009388:Neostigmine; D013390:Succinylcholine; D000077123:Rocuronium