国产舒芬太尼用于术后静脉自控镇痛的疗效和安全性——多中心、随机、双盲、平行对照临床研究

Objective To evaluate efficacy and safety of sulfentanyl (China) for PICA in surgical patients with general anes-thesia in a multiple-center, randomized, double-blind, parallel study. Methods 200 ASA grade Ⅰ -Ⅱ patients aged 18-55 undergo-ing surgery with general aneathesia enrolled from 3 hospitals were randomly and double-blindly divided into 2 groups: sulfentanyl (China, n=100) versus sulfentanyl(German, n=100). Sulfentanyl(China 0.1 μg/kg or German)was given before the end of surgery. VAS scores less than 3 after patient awake and PCA started after extubation(200 μg sulfentanyl was diluted with 50 ml saline solution, background dose 0.5 ml/h,bolus of 0.5 ml with lockout interval 15 min, continuous infusion 48 h). Vital signs including BP, HR, PR, SpO2 and side effects such as nausea, vomiting, urine retention, pruritus, breath depression, etc. And VAS scores with patients in quiet and cough were recorded at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. The total number of PCA, the total effective number of PCA, and the ratio of both and other analgesics as well as the satisfactory degree of patients and the cumulative suffen-tanyl consumption were recorded at 24 h. Results There were no significant difference of BP, HR, PR, SpO2 and the adverse effect and VAS scores in quiet and cough between two groups at the beginning of infusion at 0, 1, 4, 12, 24, 48 h. There were no signifi-cant difference of the total number of PCA, the total effective number of PCA and other analgesics as well as the satisfactory degree of patients and the total dosage of sulfentanyl at 24 h. Conclusion The sulfentanyl (China) had satisfactory effects of postoperative analgesia and had no significant side effects compared with sulfentanyl (German). The efficacy and the side effects of both drugs had no significant difference.

Efficacy and safety of sulfentanyl(China) for patient-contrulled intravenous analgesia (PICA) in surgical patients with general anesthesia: a multiple-center, randomized, double-blind, parallel study