Background Combining oxygen facemask with apnoeic oxygenation using high-flow-nasal-oxygen (HFNO) for preoxygenation in the operating room has not been studied against standard oxygen facemask alone. We hypothesized that facemask-alone would be associated with lower levels of lowest end-tidal oxygen (EtO2) within 2 min after intubation in comparison with facemask combined with HFNO. Methods In an international prospective before–after multicentre study, we included adult patients intubated in the operating room from September 2022 to December 2022. In the before period, preoxygenation was performed with facemask-alone, which was removed during laryngoscopy. In the after period, facemask combined with HFNO was used for preoxygenation and HFNO for apnoeic oxygenation during laryngoscopy. HFNO was maintained throughout intubation. The primary outcome was the lowest EtO2 within 2 min after intubation. The secondary outcome was SpO2 ≤ 95% within 2 min after intubation. Subgroup analyses were performed in patients without and with obesity. This study was registered 10 August 2022 with ClinicalTrials.gov, number NCT05495841. Results A total of 450 intubations were evaluated, 233 with facemask-alone and 217 with facemask combined with HFNO. In all patients, the lowest EtO2 within 2 min after intubation was significantly lower with facemask-alone than with facemask combined with HFNO, 89 (85–92)% vs 91 (88–93)%, respectively (mean difference − 2.20(− 3.21 to − 1.18), p < 0.001). In patients with obesity, similar results were found [87(82–91)% vs 90(88–92)%, p = 0.004]; as in patients without obesity [90(86–92)% vs 91(89–93)%, p = 0.001)]. SpO2 ≤ 95% was more frequent with facemask-alone (14/232, 6%) than with facemask combined with HFNO (2/215, 1%, p = 0.004). No severe adverse events were recorded. Conclusions Combining facemask with HFNO for preoxygenation and apnoeic oxygenation was associated with increased levels of lowest EtO2 within 2 min after intubation and less desaturation.
Introduction So far, the recovery quality after general anesthesia is still unsatisfied. Nalmefene is a drug to treat opioid overdose and reverse opioid actions. We aim to investigate the efficacy of nalmefene on optimizing the recovery quality of patients after general anesthesia. Methods It is a prospective, placebo-controlled, two-arm parallel groups, multicentre, double-blind, randomized (PPPMDR) clinical trial. The participants (n = 520) will be randomly assigned into two groups. Each patient will receive either: a single dose of nalmefene 0.25 µg/kg in the intervention group, or the same volume of 0.9% NaCl solution in the control group at the end of the surgery. The primary outcome will be the time interval between the end of anaesthesia and recovery endpoints achieved (Aldrete recovery score ≥ 9) in post-anesthesia care unit (PACU). The other variables are the time interval from the end of operation to extubation; Richmond Agitation Sedation Scale (RASS) score at extubation; the time at Montreal Cognitive Assessment Scale (MoCA) orientation score ≥ 5; visual analog scale (VAS) score and adverse effects including postoperative nausea and vomiting (PONV), and pruritus in PACU and 24 h postoperatively. Analysis This trial aims to study whether small dose of nalmefene can shorten the time from the end of surgery to Aldrete score ≥ 9 and improve opioid-induced side effects.This trial focuses on providing the reliable clinical evidence for satisfactory quality of recovery. Ethics and dissemination This clinical trial has been approved and supported by the ethics committee of the Renji Hospital, Shanghai Jiaotong University, School of Medicine (KY2020-150); Shanghai Tongren Hospital (2021–030-01);The First Affiliated Hospital of Guangxi Medical University (2021–032); and The First Affiliated Hospital of Zhengzhou University(2021-KY-0495–003). Analysis of the study results will be submitted to a peer-reviewed journal for publication. Trial registration ClinicalTrials.gov, NCT04713358, Registered on September 23, 2021.
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