Objective To explore the clinical effect of different doses of alfentanil combined with low-dose propofol in painless colonoscopy in elderly patients.Methods A total of 120 elderly patients undergoing elective painless colonoscopy from January to March 2022,aged 65 to 80 years,gender unlimited,body mass index(BMI)18-28kg/m2,American Society of Anesthesiologists(ASA)grade Ⅰ～Ⅱ.Patients were included in the three groups by random number tables:alfentanyl 5μg/kg(N1),alfentanyl 7.5μg/kg(N2),and alfentanyl 10μg/kg(N3),40 patients in each group.Record the heart rate,mean arterial pressure,and oxygen saturation were recorded before anesthesia(T1),after anesthesia induction(T2),colonoscopy(T3),colonoscopy reaching the ileocecum(T4),and at the end of examination(T5).The success rate of anesthesia sedation,dosage of propofol,sedative induction time,colonoscopy time,sedative recovery time,use of vasoactive drugs and physician satisfaction of the three groups were recorded.The incidence of intraoperative hypoxemia,hypotension,spontaneous ycardia,bradycardia,postoperative nausea and dizziness,and postoperative fatiguesyndrome(POFS)and the occurrence of adverse reactions.Results Compared with T1,the mean arterial pressure in T2-T5 patients decreased significantly(P＜0.05),and the heart rate at T3 increased significantly(P＜0.05)in N1,the total dosage,induction time,induction time,awakening time and vasoactive drug use were decreased in N2 and N3,and the success rate of anesthesia sedation was significantly increased(P＜0.05).Comparing the N2 group,physician satisfaction decreased in the N1 and N3 groups(P＜0.05).The incidence of intraoperative hypotension and postoperative POFS decreased in the N2 and N3 groups(P＜0.05)and in the N1 and N2 groups(P＜0.05).Conclusion Afunentanil 7.5pg/kg compound propofol can be used safely and effectively for painless colonoscopy in elderly patients,and the incidence of adverse reactions is low,which improves the quality of postoperative recovery of patients,and is worthy of clinical promotion and application.

Objective:This study aimed to discuss the risks associated with investigator-initiated pediatric drug clinical trials in terms of drug management and put forward relevant suggestions to improve the standardization and quality of pediatric clinical trials.Methods:The risk in the implementation of pediatric drug clinical trials initiated by domestic researchers were discussed and the countermeasures were put forward by reviewing literature, laws and regulations, and combining with the problems related to research drugs in project management.Results:In investigator-initiated pediatric drug clinical trials, the variety of research drug sources, such as sponsor donations, hospital pharmacy supplies, and community pharmacy provisions, posed distinct management risks that would require tailored attention. Moreover, the specific risk of pediatric medication should be fully considered during study execution. It was imperative for medical institutions to strengthen comprehensive management of research drugs to ensure the trial′s smooth operation.Conclusions:Investigator-initiated pediatric drug clinical trials serve as valuable supplements that expand new drugs′ trial scope for children. While actively conducting these trials, it is recommended that medical institutions should strengthen project approval reviews from the perspectives of drug supply, subject compensation and child dosage form, implement centralized management of research drugs, attach importance to ethical review of adverse drug events, strengthen personnel training and leverage information settlement, so as to improve work efficiency and research quality-ultimately providing support for pediatric pharmaceutical development efforts as well as promoting high-quality advancements within Chinese pediatrics medicine.