Effect Of Desflurane On Postoperative Sleep Quality In Patients Undergoing Elective Breast Surgery:A Non-inferiority Randomized Controlled Trial

Background: Postoperative sleep disorders have a high prevalence in patients undergoing elective breast surgery,increasing the incidence of postoperative delirium,adverse cardiovascular events,and affecting patients’ postoperative recovery and prognosis.General anesthetic drugs have been shown to be independent risk factors for postoperative sleep disorders.Desflurane,a new inhalation anesthetic,is widely used in clinical anesthesia,but its effect on postoperative sleep is unclear.Therefore,the aim of this study was to investigate the effects of desflurane on postoperative sleep with the aim of providing guidance for perioperative patient management.Methods: This study was designed as a single-center,non-inferiority randomized controlled trial.Inclusion criteria were patients who were undergoing elective radical breast cancer surgery,aged 18-75 years,classified as Class I or II by the American Society of Anesthesiologists Physical Status Classification System,and voluntarily participated in the study and signed the informed consent form;Exclusion criteria were preoperative adjuvant chemotherapy,current taking psychotropic,opioid,anxiolytic and hypnotic medications,combination of other cancers,with cognitive impairment,known or treated obstructive sleep apnea;serious adverse events occurred during perioperative period,duration of anesthesia > 6 hours,and abnormal resuscitation in the anesthesia resuscitation room.Subjects were randomly assigned to receive either propofol(reference group)or desflurane(experimental group)under anesthetic maintenance in a ratio of 1:1.A total of 110 subjects met the inclusion and exclusion criteria after surgery and entered the follow-up stage.The subjects’ sleep quality,anxiety and depression were assessed before operation,on postoperative 3rd,7th and 30 th days using the Pittsburgh Sleep Quality Index(PSQI)Scale,Self-Rating Anxiety Scale(SAS),and Self-Rating Depression Scale(SDS),respectively.The subjects’ objective total sleep time(TST),rapid eye movement(REM)and wakefulness after sleep(WASO)were measured from preoperative to postoperative day 3 using the Fibit Charge 2TM wristwatch.The PSQI score on postoperative 3rd day was used as the primary outcome,and the PSQI scores on postoperative 7th and 30 th days and the SAS and SDS scores on postoperative 3rd,7th and 30 th days,as well as objective sleep parameters within 3 days after surgery,were used as secondary outcomes.Statistical analysis was performed according to intention to treatment(ITT)andper-protocol set(PPS),respectively.Quantitative normally distributed data were statistically described by mean ± standard deviation,non-normal data by median[interquartile range(IQR)],and categorical data by their frequency(%).Group comparisons of quantitative data were performed using the group t-test or the Wilcoxon rank sum test according to whether they are normally distributed and have equal variances;group comparisons of categorical variables were performed using thec2 or Fisher exact test,and ranked data were compared using the Wilcoxon rank sum test.For repeated measures data,according to whether they were normally distributed or not,the linear mixed model(LMM)or the generalized estimating equation model(GEE)were conducted,respectively,where group,time,and the interaction of group and time terms were taken into consideration.Results: There was no significant difference in the distribution of preoperative,intraoperative and postoperative characteristics between the propofol group and the desflurane group,with a balanced distribution between the groups.For the primary outcome,the PSQI scores of patients in the propofol and desflurane groups on postoperative 3rd day were 7.65 ± 3.16 and 8.47 ± 3.46,respectively.The mean difference in PSQI scores and 95% confidence interval(CI)between the two groups were 0.82(-0.43,2.07),with the lower limit of the 95% CI being greater than the non-inferiority margin(-2.4)and the non-inferiority p-value <0.001.For the secondary outcomes,no significant differences were found between the PSQI scores of patients in the propofol and desflurane groups on postoperative 7th and 30 th days;there were no significant differences in SAS scores and SDS scores between the two groups on postoperative 3rd,7th,and 30 th days;among the objective sleep parameters,postoperative TST was significantly increased in the propofol and desflurane groups compared to preoperative,and postoperative REM and WASO were significantly increased in the propofol group compared to preoperative,whereas no such effect was observed in the desflurane group.However,these objective sleep parameters still have no significant differences between propofol and desflurane groups preoperatively or postoperatively.In the subgroup analysis according to preoperative sleep disorder or not,the 95% CI for the mean difference in PSQI scores on postoperative 3rd day between the desflurane and propofol groups was greater than the non-inferiority threshold and the non-inferiority p-value was <0.025,and there was no significant difference in PSQIscores on postoperative 7th and 30 th days between the two groups.Conclusion: As a new inhalation anesthetic,the effect of desflurane on postoperative sleep quality in breast surgery patients is noninferior to that of the classic intravenous anesthetic drug propofol,but these two drugs may have different effects on postoperative sleep architecture.The management of postoperative sleep quality in patients undergoing surgery maintained by desflurane anesthesia should be taken into account in clinical practice.