Efficacy And Safety Of Ciprofol In Anesthesia Of Gynecological Short Surgery

ObjectiveTo evaluat the efficacy and safety of ciprofol for anesthesia in patients undergoing short and minor gynecological diagnosis and surgery.MethodsA randomized,double-blind,parallel-group,active-controlled clinical study was adopted.Subjects meeting the inclusion criteria will be randomly allocated to the ciprofol group or the propofol group at a ratio of 1:1.The enrolled patients were given a 1 s to 2 s intravenous bolus of 50 pg of fentanyl at 1 min before administration of the study drug,followed by a 30 s±5 s intravenous bolus of ciprofol 0.4 mg/kg or propofol 2.0 mg/kg.During the anesthesia induction period,the depth of anaesthesia is evaluated using the MOAA/S score.When the patient achieves the required depth of sedation/anesthesia(MOAA/S≤1),the procedure can begin;if MOAA/S>1 after 2 min of the first administration,additional study drug is required,with an additional bolus time of 10 s±5 s,a dose of 1/2 of the first dose(ciprofol 0.2 mg/kg or propofol 1.0 mg/kg)and an interval of≥2 min between each additional dose.During the anesthesia maintenance period,if the patient shows signs of lighter anesthesia,such as body movement,eyes-opening,accelerated respiration rates or heart rates,the anesthesiologist may add additional study drugs,and the additional dose,additional dosing rate and interval are the same as the anesthesia induction period in order to maintain a good anesthesia depth and ensure the successful completion of the surgery.The primary end point is the success rate of anesthesia induction(MOAA/S≤1)after receiving the induced dose of the study drug(including 1/2 additional initial dose at the time of induction)in all the patients in this group.The secondary end points include the anesthesia induction time,the time to be fully awake,the use of the study drugs,and anesthesia satisfaction.Safety indicators include injection pain,adverse events/reactions of central nervous system,circulatory system,respiratory system,and others.ResultsIn this study,a total of 94 subjects were randomly enrolled,47 in the control group and 47 in the experiment group.The primary end point is the success rate of anesthesia induction(both 100%)The Secondary econdary end points is anesthesia induction time.The difference in anesthesia induction time between the two groups was statistically significant,and the time in ciprofol group was slightly longer than that in propofol group,with 11.81 s slower on average.The difference in anesthesia induction time for a single dose between the two groups was statistically significant,and the time in the ciprofol group was slightly longer than that in the propofol group,with 6.45 s slower on average.The cumulative total amount in the ciprofol and propofol group was 0.60±0.19 mg/kg and 3.09±0.72 mg/kg respectively,and the difference was statistically significant(P<0.05).The additional rate during induction period(12.8%vs.6.4%),the time to be fully awake(11.93±3.44 min vs.10.78±2.28 min),the average anesthesia maintain time(8.91±2.94 min vs.8.15±2.50 min),the anesthesia satisfaction of anesthesiologists(5.1±2.3 vs.5.4±2.5),the anesthesia satisfaction of gynecologists(8.9±2.8 vs.8.9±2.7),and the anesthesia satisfaction of patients(both full scores)between the two groups(P>0.05).The incidences of adverse reactions in the ciprofol and propofol group were 76.6%and 100%respectively,and the difference was statistically significant(P<0.05).The incidences of injection pain(2.1%vs.70.2%),apnea(31.9%vs.74.5%)and hypotension(2.1%vs.21.3%)in the ciprofol group were significantly lower than those in the propofol group(P<0.05).The incidences of respiratory depression,glossocoma,hypoxemia,amyostasia,bradycardia and chest tightness were similar in the two groups.Significant changes in the vital signs occurred in the both groups after administration,and systolic blood pressure,mean arterial blood pressure and diastolic blood pressure(except for a few time points)were all lower than those before administration.However,compared to the time points of being awake,the blood pressure in the propofol group was lower or similar after administration,while that in the ciprofol group was higher or similar.At the same time points(except a few time points)after administration,the blood pressure in the ciprofol group was significantly higher compared with the propofol group.The heart rate in the propofol group was first fast,then slow,or did not change significantly,while the heart rate in the ciprofol group started to slow down or did not change significantly after 1 min of administration,and there was no difference between the two groups at each time point.At some time points after administration,SpO2,PetCO2 and RR in the two groups were significantly lower or higher compared with those before administration.Compared between the two groups,SpO2 in the ciprofol group was significantly higher than that in the propofol group at 2 min and 9 min after administration.There was no significant difference between the two drugs on PetCO2.RR in the ciprofol group was significantly faster than that in the propofol group at 1 min after administration.After administration,the average number of apnea in the ciprofol group was significantly less than that in the propofol group,while there was no significant difference in the average number of respiratory depression,the average number of glossocoma,the onset time of the first apnea,the onset time of the first respiratory depression,the onset time of the first glossocoma,the duration time of the first apnea,the duration time of the first respiratory depression and the duration time of the first glossocoma between the two groups(P>0.05).The cognitive abilities(MMSE scores)were in the normal range in both groups at the time to be fully awake and the next day’s follow-up.The difference in Brice score between the two group at the time to be fully awake and the next day’s follow-up was not statistically different(P>0.05).During the treatment,no subject experienced intraoperative awareness or suspected intraoperative awareness.ConclusionsThe effect of 0.4mg/kg Ciprofol is is the same as that of 2 mg/kg propofol.Ciprofol has the advantages of quick effect,quick recovery,high potency,high satisfaction of surgeons and patients,and is suitable for anesthesia in short gynecological diagnosis and Surgery.0.4mg/kg Ciprofol has almost no injection pain,mild respiratory and circulatory inhibition and good safety.The sleeping quality and recovery quality of Ciprofol are satisfactory.