纳布啡对磷丙泊酚钠全身麻醉后瘙痒/感觉异常影响的研究

Study on the effect of nalbuphine on pruritus/paresthesia induced by fospropofol disodium under general anesthesia

目的探讨纳布啡对磷丙泊酚钠全身麻醉后瘙痒/感觉异常的影响及其机制。方法研究设计为前瞻性、单中心、随机双盲对照试验,研究对象选自2022年4至5月在将空军军医大学西京医院择期行全身麻醉下手术的患者,采用随机序列表法被随机分为纳布啡组和对照组。2组患者均采用磷丙泊酚钠全身麻醉,纳布啡组患者在手术结束前30 min给予静脉注射纳布啡0.2 mg/kg(0.1 ml/kg),对照组注射等容积的0.9%氯化钠注射液。分别于麻醉诱导前5 min和苏醒后5 min采集2组患者静脉血样本,检测血清白细胞介素6(IL⁃6)、肿瘤坏死因子α(TNF-α)和S⁃100钙结合蛋白β(S⁃100β)。主要研究指标为拔管后30 min瘙痒/感觉异常的发生率,次要研究指标包括呼之睁眼时间,拔管后30 min内最高瘙痒/感觉异常评分,恶心、呕吐评分及疼痛评分,术后24 h瘙痒/感觉异常发生率和患者对麻醉的满意度评分,以及术后血清炎性标志物水平。结果纳入本研究的患者共98例,每组49例。2组患者的性别、年龄、体重指数、美国麻醉医师协会分级、手术类型、手术时长、麻醉时长的差异均无统计学意义(均P>0.05)。纳布啡组患者拔管后30 min瘙痒/感觉异常发生率和瘙痒/感觉异常评分均低于对照组,差异均有统计学意义[24.5%(12/49)比61.2%(30/49),P<0.001;4(2,5)分比6(5,7)分,P=0.031]。术后24 h,纳布啡组患者麻醉满意度评分高于对照组,差异有统计学意义[8(7,9)分比6(3,7)分,P=0.042]。与对照组相比,术后纳布啡组患者血清IL⁃6较低[(329.5±105.5)ng/L比(398.5±102.6)ng/L,P=0.033)],而TNF⁃α和S-100β水平2组间的差异无统计学意义(均P>0.05)。结论纳布啡可显著降低磷丙泊酚钠全身麻醉后瘙痒/感觉异常的发生率,提高患者麻醉满意度,其机制可能与纳布啡抑制炎症反应有关。

Objective To explore the effect and its mechanism of nalbuphine on pruritus/pares⁃thesia induced by fospropofol disodium under general anesthesia.Methods The study was designed as a prospective,single⁃center,randomized,double⁃blind controlled trial.Patients scheduled for surgery under general anesthesia in Xijing Hospital,Air Force Medical University from April to May 2022 were entered and randomly divided into nalbuphine group and control group using the random sequence table method.Patients of both groups were given general anesthesia with fospropofol disodium.Thirty minutes before the end of the surgery,patients in the nalbuphine group received intravenous injection of nalbuphine 0.2 mg/kg(0.1 ml/kg),while those in the control group received intravenous injection of an equal volume of 0.9%sodium chloride injection.Venous blood samples of patients in the 2 groups were collected 5 minutes before anesthesia induction and 5 minutes after awakening to detect levels of serum interleukin 6(IL⁃6),tumor necrosis factorα(TNF-α),and S⁃100 calcium binding proteinβ(S⁃100β).The primary indicator of the study was the inci⁃dence of pruritus/paresthesia within 30 minutes after extubation;the secondary indicators included time to eye opening upon calling,the maximum pruritus/paresthesia score within 30 minutes after extubation,nausea/vomiting score,pain score,the incidence of pruritus/paresthesia within 24 hours after operation,the score of patient satisfaction to anesthesia,and the levels of postoperative serum inflammatory markers.Results A total of 98 patients enrolled the study,49 in each group.There were no statistically significant differences in gender,age,body mass index,American Society of Anesthesiologists grade,operation type,operation time,or anesthesia time of patients between the 2 groups(all P>0.05).The incidence of pruritus/paresthesia and the score of pruritus/paresthesia 30 minutes after extubation were lower in the nalbuphine group than those in the control group,with statistically significant differences[24.5%(12/49)vs.61.2%(30/49),P<0.001;4(2,5)vs.6(5,7),P=0.031].At 24 hours of postoperation,the score of patient satisfaction to anesthesia in the nalbuphine group was higher than that in the control group,with a statistically significant difference[8(7,9)vs.6(3,7),P=0.042].Compared with the control group,the postoperative serum IL⁃6 in patients of the nalbuphine group was significantly lower[(329.5±105.5)ng/L vs.(398.5±102.6)ng/L,P=0.033],while differ⁃ences in levels of TNF-αand S-100βwere not statistically significant(all P>0.05).Conclusion Nalbu⁃phine can significantly reduce the incidence of pruritus/paresthesia induced by fospropofol disodium under general anesthesia and improve the patient satisfaction to anesthesia,and its mechanism may involve the inhibition of inflammatory response by nalbuphine.