Methods
bradycardia, hypoxia, muscle paralysis, hernia, nausea, vomiting
RESPIRATORY DISEASE, CARDIOVASCULAR DISEASE, NEUROMUSCULAR JUNCTION DISEASE, ADVERSE EVENTS, HYPOXIA, LIVER DISEASE, WEST, SECONDARY
This was a single-center, parallel, randomized, controlled trial, and was approved by the Ethics Committee of West China Hospital, Sichuan University. The study was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-17012890). The hospital that carried out this study is a research hospital in western China. This study included pediatric patients who underwent inguinal hernia repair under general anesthesia, used a muscle relaxant during surgery, had American Society of Anaesthesiologists Physical Status I–II, and were aged 3 months to 12 years. Pediatric patients with neuromuscular junction disease, cardiovascular disease, respiratory disease, or liver disease, as well as those who used drugs that may affect neuromuscular function in the past 3 months, were excluded. The parents or guardians of the involved children signed informed consent before surgery. The random number table was generated by a software program (EXCEL 2010, Microsoft, USA) and was sealed in an opaque envelope. The study was double blinded to the data collectors and the parents or guardians of the participants.Guardians were allowed to accompany their children to the operating room (OR) until the children are sedated. Hence no pre-anesthesia medication was used. Anesthesia was induced by propofol, fentanyl, and cis-atracurium, and then endotracheal intubation was performed. Sevoflurane was used for maintenance of anesthesia. An electrocardiogram, pulse oxygen saturation, non-invasive blood pressure, and end-tidal carbon dioxide were routinely monitored during surgery. The ventilator settings were 8–10 ml/kg for tidal volume, 12–20 bpm for the respiratory rate, and the ratio of inspiration time to expiration time was 1:2. Neuromuscular function of the patient was monitored immediately after induction of anesthesia, and monitoring continued until the patient exited the OR. The enrolled pediatric patients were divided into the experimental group and the control group. For children in the experimental group, 0.02 mg/kg neostigmine and 0.01 mg/kg atropine were routinely administered after recovery of spontaneous breathing. Anesthesiologists were blinded to the TOF ratio of children in the experimental group. Children in the control group were administered neostigmine under the neuromuscular monitoring guided after surgery. When the TOF ratio was between 0.4 and 0.9, 0.02 mg/kg neostigmine and 0.01 mg/kg atropine were administered. If the TOF ratio was >0.9, neostigmine and atropine were not provided. The extubation indications and the criteria for exiting the OR were under the control of the anesthesiologist who performed the anesthesia. Tidal volume, respiratory rate, end-tidal carbon dioxide, status of consciousness, and TOF ratios were recorded before extubation. After extubation, children were transferred to the post-anesthesia care unit (PACU). Children were followed up until 1 day after the surgery. The follow-up nurses were not aware of the grouping of the participants.The primary outcome was the incidence of rNMB immediately after extubation: rNMB defined as the TOF ratio was <0.9). The secondary outcomes were as follows: (1) the incidence of neostigmine-induced muscle paralysis — the decrease in the TOF ratio after administration of neostigmine. (2) end of surgery - extubation interval — the time from the end of surgery to endotracheal extubation; (3) end of surgery - exit OR interval — the time from the end of the surgery to when the patient was transferred out of the OR; (4) the length of PACU stay; (5) the incidence of hypoxia in the PACU (pulse oxygen saturation <90%); (6) the number of children who required assisted ventilation during the PACU stay — the patients need mask ventilation, larynx mask or endotracheal intubation; (7) neostigmine-related adverse events, such as nausea, vomiting, and bradycardia.According to the previous studies, the incidence of rNMB was 15% in children with routinely using neostigmine to reverse atracurium [