Objectives This randomised controlled trial aims to evaluate the impact of low-dose intravenous nalmefene on anaesthesia recovery in adult patients aged 18–65 undergoing surgery under general anaesthesia. Design This was a multicentre, randomised, double-blind trial with two parallel arms clinical study. Setting Four hospitals from China Participants A total of 514 patients aged 18–65 who underwent elective orthopaedic, urologic and thoracic surgeries. Interventions On completion of skin suturing, the intervention group received a single intravenous dose of nalmefene (0.25 µg/kg). The control group received an equivalent volume of normal saline at the same time point. Primary and secondary outcome measures The primary outcome was the interval time between the end of anaesthesia and the Aldrete score ≥9 being achieved in the postanaesthesia care unit (PACU). The secondary endpoints included 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 analogue scale (VAS) score in PACU and 24 hours postoperatively. Results 514 patients were included in the Intention-to-Treat (ITT) analysis. The time interval between the end of anaesthesia and Aldrete score reached ≥9 in PACU was significantly shorter in the intervention group than in the control group (mean (SD) 24.8 (11.8) min vs 33.8 (12.5) min; 95% CI −8.8 (−10.8 to −6.7); p<0.001). Furthermore, the time interval from the end of surgery to extubation was shorter in the intervention than in the control group (mean (SD) 20.0 (9.9)min vs 27.6 (11.6) min; 95% CI −7.6 (−9.43 to −5.7), p<0.001). The time at Montreal cognitive assessment score ≥5 was also shorter in the control than in the intervention group (mean (SD) 20.0 (15.9) min vs 27.0 (20.5) min; 95% CI −7.0 (−10.2 to −3.8); p<0.001). Compared with the control group, the intervention group had better analgesic effect at the recovery endpoint (P Aldrete score ≥A was achieved as well as lower 24 hours points postoperatively (p<0.05)). Conclusions In patients aged 18–65 who underwent elective orthopaedic, urologic and thoracic surgeries, low-dose nalmefene administered at the end of surgery can accelerate postanaesthesia recovery without compromising analgesic effects. Trial registration number NCT04713358 .
Ma et al. (Sun,) studied this question.
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