2. Materials and Methods
nausea or vomiting, bradycardia, hypoxia, loss of verbal response, forceful expulsion of gastric contents, amnesia, vomit, nausea, vomiting, hypotension, Nausea, PONV, Bradycardia, delirium, postoperative pain, tachycardia, sleep disorder, loss of consciousness, pain, dizziness, headache
POSTOPERATIVE COMPLICATIONS, MORBID OBESITY, HYPOXIA, PULMONARY EDEMA, SECONDARY, RESPIRATORY COMPLICATIONS, EVENTS, MIDDLE EAR, BRONCHOSPASM
This prospective, double-blind, randomized trial was approved by the Institutional Review Board and was registered at the Clinical Research Information Service on cris.nih.go.kr. Before enrollment, written informed consent was obtained from all patients who agreed to participate in this study. This study was conducted in agreement with the principles described in the Declaration of Helsinki.The patients enrolled in this study were people aged between 20 and 80 years old who were scheduled to undergo middle ear surgery under general anesthesia at our hospital from February to October 2022 and had American Society of Anesthesiologists physical status class I, II, or III. Patients hypersensitive to remimazolam and other benzodiazepines, previously treated with corticosteroids within 6 months, undergoing emergency surgery, with morbid obesity (body mass index (BMI) > 35 kg/mThe patients were randomly allocated to either the remimazolam (ByfavoNo premedication was administered prior to anesthesia. When entering the operating room, the patients were continuously monitored using electrocardiography, noninvasive arterial blood pressure, pulse oximetry, capnography, and bispectral index (BIS) monitoring. Nasopharyngeal temperature was also monitored and maintained at 36.5 ± 0.5 °C during surgery.The patients assigned to the remimazolam group received continuous infusion of remimazolam at a rate of 12 mg/kg/h and remifentanil at 0.5 mcg/kg/min for induction. The infusions were continued until the confirmation of loss of consciousness (LoC), which was clarified by loss of verbal response and eyelash reflex. After LoC, endotracheal intubation was facilitated using rocuronium (0.8 mg/kg). The patients were mechanically ventilated with a tidal volume of 6–8 mL/kg using 40% oxygen, and air mixture and respiratory rate were adjusted to maintain an end-tidal COIn the sevoflurane group, anesthesia was induced with continuous infusion of remimazolam at a rate of 12 mg/kg/h and remifentanil at 0.5 mcg/kg/min for induction. After confirming LoC, the patients were intubated using an endotracheal tube after the administration of rocuronium (0.8 mg/kg). The patients were mechanically ventilated with a tidal volume of 6–8 mL/kg using 40% oxygen, and air mixture and respiratory rate were adjusted to maintain an EtCOHypotension was defined as decreased mean arterial pressure (MAP), <65 mmHg, which was calculated automatically during monitoring, and when it occurred, phenylephrine 100 mcg or ephedrine 10 mg was adequately administered with or without loading of fluid volume (100 mL). Bradycardia and tachycardia were defined as decreased heart rate (HR), <50 beats per minute (bpm), and increased HR, >100 bpm, respectively. For postoperative analgesia, ibuprofen 400 mg was intravenously administered routinely within approximately 6 h of surgery. Intravenous ketorolac 30 mg was administered when the numerical rating scale (NRS) of pain intensity exceeded 4 and when the patient required pain relief. Opioids, including fentanyl, were not postoperatively administered. Ramosetron (NaseaEvery assessment was performed by the anesthesiologists, who were blinded to the allocated groups and did not participate in the induction of anesthesia to the patients. The primary outcome of this study was the incidence rate of PONV 0–12 h after middle ear surgery under general anesthesia. One or more episodes of nausea or vomiting were considered PONV. Nausea was defined as the subjectively unpleasant feeling associated with the perception of the urge to vomit, and vomiting was defined as the forceful expulsion of gastric contents from the mouth. The incidence rate of PONV was estimated according to the questionnaire provided to the patients.The secondary outcomes were the incidence rate of PONV 12–24 and 24–48 h after surgery; severity of PONV, which was measured using the nausea score (0: no nausea; 1: mild nausea; 2: moderate nausea; 3: severe nausea) 0–12, 12–24, and 24–48 h after surgery; incidence of vomiting 0–48 h after surgery; administration of rescue antiemetics; postoperative pain score; need of rescue analgesics; incidence rate of adverse hemodynamic events, including hypotension and bradycardia and/or tachycardia; total amount of intravenous phenylephrine and ephedrine use; hemodynamic data, including MAP and HR before induction (T0), 1 min after induction (T1), 30 min after induction (T2), 1 min before emergence (T3), 1 min after emergence (T4), and 30 min after emergence (T5); Modified Observer’s Alertness/Sedation Scale (MOAA/S) score at T0, T1, T2, T3, T4, and T5; total amount of anesthetics and remifentanil administered throughout surgery; time to extubation; time to eye opening; time to cooperation; time to Aldrete score > 9; duration of hospital stay time after surgery; and postoperative complications, including headache, dizziness, respiratory complications such as hypoxia, pulmonary edema, and bronchospasm, sleep disorder, amnesia, and delirium. All recorded parameters were evaluated within 48 h of surgery.Sample size was calculated using nQuery AdvisorVariables are summarized by frequency and percentage for categorical data and mean ± standard deviation. Group differences were assessed using the chi-squared or Fisher’s exact test for categorical data and independent 