单次静脉注射小剂量瑞马唑仑降低剖宫产术后寒战风险并促进术后恢复:一项随机双盲对照试验OA

Objective Post-cesarean shivering under combined spinal-epidural anesthesia(CSEA)is highly prevalent,which can cause to maternal discomfort,increase oxygen consumption,interfere with vital sign monitoring,and potentially lead to adverse cardiovascular and respiratory events.Remimazolam,a novel ultrashort-acting benzodiazepine,has been shown to reduce postoperative shivering in general anesthesia.This study aims to evaluate the prophylactic effect of remimazolam on post-cesarean shivering under CSEA and its impact on maternal recovery quality.Methods A prospective randomized double-blind placebo-controlled trial was conducted on 140 singleton full-term parturients(aged 24-40 years,ASA physical status II,BMI≤35 kg/m²)undergoing elective cesarean section under CSEA in our hospital from June to December 2025.They were randomly assigned to a remimazolam group(Group Remimazolam,receiving a single intravenous injection of remimazolam 0.2 mg/kg immediately after delivery and umbilical cord clamping,n=70)and a control group(Group Control,n=70,receiving an equal volume of normal saline).The incidence of moderate-to-severe shivering within 90 min after neuraxial anesthesia[assessed using the Bedside Shivering Assessment Scale(BSAS)].quality of recovery on postoperative days 1 and 2[measured by the 15-item Quality of Recovery(QoR-15)scale,covering 5 dimensions:emotional state,psychological support,physical comfort,physical independence,and pain],Observer's Assessment of Alertness/Sedation(OAA/S)scores within 90 min after drug administration,and intraoperative adverse reactions(hypotension,bradycardia,nausea.vomiting and dizziness)were compared between the 2 groups.Results There were no statistically significant differences in baseline characteristics between the 2 groups,including age,body weight,gestational age,primipara ratio,anesthetic block level,intraoperative blood loss,or operative duration(all P>0.05).① For the primary outcome,the overall incidence of moderate-to-severe shivering in Group Remimazolam was 27.1%(19/70),significantly lower than that in Group Control[55.7%(39/70),P<0.001].Remimazolam reduced the risk of moderate-to-severe shivering by 62%compared with the risk in the Group Control(HR=0.38,95%CI:0.22 to 0.67,P=0.000 4).During the 0-30 min period,the incidence of moderate-to-severe shivering was significantly lower in Group Remimazolam than in Group Control(10.0%vs 25.7%,P=0.027).②For secondary outcomes,the QoR-15 total score on postoperative day 1 was 126(124,128)in Group Remimazolam,which was significantly higher than that in the Control group[116(115,118),P<0.001];on postoperative day 2,the Remimazolam group scored 141(140,143),which was significantly higher than that in the Control group[133(130,135),P<0.001].Group Remimazolam showed significantly higher scores in the dimensions of emotional state,psychological support,and physical comfort(all P<0.001),whereas there were no statistically significant differences between the 2 groups in the dimensions of physical independence or pain(P>0.05).The OAA/S score at 15 min after drug administration in the Remimazolam group was 5(4,5),which was lower than that in the Control group[5(5,5),P=0.004],and returned to the level of the control group after 30 min(P>0.05).No significant differences were observed in the incidence of bradycardia,hypotension,nausea,vomiting or dizzines between the 2 groups(all P>0.05).Conclusion A single intravenous dose of 0.2 mg/kg remimazolam administered immediately after delivery during cesarean section under CSEA can significantly reduce the risk of moderate-to-severe post-cesarean shivering by 62%,also improve the quality of maternal recovery on postoperative days 1 and 2(particularly in the dimensions of emotional state,psychological support,and physical comfort).The regimen produces only mild,reversible intraoperative sedation without increasing the risk of adverse reactions.