Kim Ha-Jung, Kim Kyung Mi, Lee Jong Lyul, Park In Ja, Choi Byung-Moon
Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, Korea.
Division of Colon and Rectal Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Trials. 2025 Jan 8;26(1):11. doi: 10.1186/s13063-025-08716-x.
Prophylactic parenteral administration of antibiotics is strongly recommended to prevent surgical site infection (SSI). Cefoxitin is mainly administered intravenously in colorectal surgery. The current standard method for administering prophylactic antibiotics in adults is to administer a fixed dose quickly before skin incision. The percentage of time that the unbound concentration is maintained above the minimum inhibitory concentration (fT > MIC) during surgery is used as a surrogate measure for the effectiveness of prophylactic antibiotics. Target-controlled infusion (TCI) is a method of administration that changes the infusion rate to maintain a constant target concentration set by the user in consideration of the patient's physical characteristics. When cefoxitin is administered using the TCI method, it is possible that fT > MIC can be well maintained while reflecting the patient's physical characteristics compared to the standard method.
This prospective, single-centre, parallel-arm, single-blinded, randomised controlled trial with a 1:1 allocation was designed to compare the effectiveness of the TCI method with that of the standard cefoxitin administration method. We shall enrol 2494 patients scheduled to undergo colon or rectal surgery. Prior to the procedure, we shall randomise each patient to the control group (standard administration method) or study group (TCI method). In the control group, 2 g of cefoxitin was dissolved in 100 ml of normal saline and administered for approximately 10 min. Redosing was performed every 2 h from the start of the first dose of cefoxitin. In the study group, 2 g of cefoxitin was dissolved in 50 ml of normal saline and administered using a commercialised TCI syringe pump until the end of surgery. It was administered at a target concentration of 80 μg/ml using the total concentration pharmacokinetic model of cefoxitin. In all groups, 2 g of cefoxitin was administered using the standard administration method 12 h after the end of surgery. The primary outcome will be the incidence of SSI. The secondary outcome will be the administered dose of cefoxitin. Preoperative, intraoperative, and postoperative data were collected.
This study will provide evidence for the effectiveness of administering cefoxitin using the TCI method compared to the standard method.
ClinicalTrials.gov, NCT05253339 , Registered on February 23, 2022 {2a, 2b}.
强烈建议预防性胃肠外使用抗生素以预防手术部位感染（SSI）。头孢西丁在结直肠手术中主要通过静脉给药。目前成人预防性使用抗生素的标准方法是在皮肤切开前快速给予固定剂量。手术期间未结合浓度维持在最低抑菌浓度以上的时间百分比（fT＞MIC）被用作预防性抗生素有效性的替代指标。靶控输注（TCI）是一种给药方法，它会根据患者的身体特征改变输注速率以维持用户设定的恒定目标浓度。与标准方法相比，当使用TCI方法给予头孢西丁时，有可能在反映患者身体特征的同时很好地维持fT＞MIC。
本前瞻性、单中心、平行组、单盲、随机对照试验采用1:1分配，旨在比较TCI方法与标准头孢西丁给药方法的有效性。我们将招募2494例计划接受结肠或直肠手术的患者。在手术前，我们将把每位患者随机分配到对照组（标准给药方法）或研究组（TCI方法）。在对照组中，将2g头孢西丁溶解于100ml生理盐水中并给药约10分钟。从第一剂头孢西丁开始每2小时重新给药一次。在研究组中，将2g头孢西丁溶解于50ml生理盐水中，并使用商业化的TCI注射泵给药直至手术结束。使用头孢西丁的总浓度药代动力学模型以80μg/ml的目标浓度给药。在所有组中，手术后12小时使用标准给药方法给予2g头孢西丁。主要结局将是SSI的发生率。次要结局将是头孢西丁的给药剂量。收集术前、术中和术后数据。
本研究将为与标准方法相比使用TCI方法给予头孢西丁的有效性提供证据。
ClinicalTrials.gov，NCT05253339，于2022年2月23日注册{2a, 2b}。
