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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.
Anesth Analg. 2016 May; 122(5):1536-45.A&A

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+Show Affiliations

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.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26974018

Citation

Stourac, Petr, et al. "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." Anesthesia and Analgesia, vol. 122, no. 5, 2016, pp. 1536-45.
Stourac P, Adamus M, Seidlova D, et al. 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. Anesth Analg. 2016;122(5):1536-45.
Stourac, P., Adamus, M., Seidlova, D., Pavlik, T., Janku, P., Krikava, I., Mrozek, Z., Prochazka, M., Klucka, J., Stoudek, R., Bartikova, I., Kosinova, M., Harazim, H., Robotkova, H., Hejduk, K., Hodicka, Z., Kirchnerova, M., Francakova, J., Obare Pyszkova, L., ... Sevcik, P. (2016). 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. Anesthesia and Analgesia, 122(5), 1536-45. https://doi.org/10.1213/ANE.0000000000001197
Stourac P, et al. 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. Anesth Analg. 2016;122(5):1536-45. PubMed PMID: 26974018.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Stourac,Petr, AU - Adamus,Milan, AU - Seidlova,Dagmar, AU - Pavlik,Tomas, AU - Janku,Petr, AU - Krikava,Ivo, AU - Mrozek,Zdenek, AU - Prochazka,Martin, AU - Klucka,Jozef, AU - Stoudek,Roman, AU - Bartikova,Ivana, AU - Kosinova,Martina, AU - Harazim,Hana, AU - Robotkova,Hana, AU - Hejduk,Karel, AU - Hodicka,Zuzana, AU - Kirchnerova,Martina, AU - Francakova,Jana, AU - Obare Pyszkova,Lenka, AU - Hlozkova,Jarmila, AU - Sevcik,Pavel, PY - 2016/3/15/entrez PY - 2016/3/15/pubmed PY - 2016/9/8/medline SP - 1536 EP - 45 JF - Anesthesia and analgesia JO - Anesth. Analg. VL - 122 IS - 5 N2 - 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. SN - 1526-7598 UR - https://www.unboundmedicine.com/medline/citation/26974018/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_ L2 - http://dx.doi.org/10.1213/ANE.0000000000001197 DB - PRIME DP - Unbound Medicine ER -