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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

Stourac, Petr MD, PhD; Adamus, Milan MD, PhD; Seidlova, Dagmar MD, PhD; Pavlik, Tomas MSc, PhD; Janku, Petr MD, PhD; Krikava, Ivo MD, PhD; Mrozek, Zdenek MD, PhD; Prochazka, Martin MD, PhD; Klucka, Jozef MD; Stoudek, Roman MD; Bartikova, Ivana MD; Kosinova, Martina MD; Harazim, Hana MD; Robotkova, Hana MD; Hejduk, Karel MSc; Hodicka, Zuzana MD, PhD; Kirchnerova, Martina MD; Francakova, Jana MD; Obare Pyszkova, Lenka MD; Hlozkova, Jarmila MD; Sevcik, Pavel MD, PhD

doi: 10.1213/ANE.0000000000001197
Obstetric Anesthesiology: Research Report

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.

Supplemental Digital Content is available in the text.Published ahead of print March 11, 2016

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.

Accepted for publication December 29, 2015.

Published ahead of print March 11, 2016

Funding: Financial support from the Czech Ministry of Health Internal Grant Agency (NT 13906-4/2012).

The authors declare no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website.

The preliminary results of this study were presented as conference abstracts and posters at the following congresses: Euroanaesthesia 2013, Barcelona, Spain; Euroanaesthesia 2014, Stockholm, Sweden; Euroanaesthesia 2015, Berlin, Germany; and Anesthesiology 2015, San Diego, CA.

Reprints will not be available from the authors.

Address correspondence to Petr Stourac, MD, PhD, Department of Pediatric Anesthesiology and Intensive Care Medicine, University Hospital Brno, Faculty of Medicine of Masaryk University, Jihlavska 20, 625 00 Brno, Czech Republic. Address e-mail to petr.stourac@gmail.com.

© 2016 International Anesthesia Research Society