PMID- 37074366 OWN - NLM STAT- MEDLINE DCOM- 20230604 LR - 20230604 IS - 1432-1041 (Electronic) IS - 0031-6970 (Linking) VI - 79 IP - 6 DP - 2023 Jun TI - The pharmacokinetics and safety of lidocaine in liver cancer patients undergoing hepatic resection. PG - 829-839 LID - 10.1007/s00228-023-03498-0 [doi] AB - PURPOSE: The purpose of this study was to explore the pharmacokinetics (PK) characteristics and safety of continuous lidocaine infusion during hepatectomy in liver cancer patients. METHODS: This study included thirty-five patients undergoing laparoscopic hepatectomy from January 2021 to December 2021. Patients received a short infusion of 1% lidocaine at a dose of 1.5 mg/kg based on ideal body weight, followed by a continuous infusion of 1 mg/kg/h during the operation. The plasma concentrations of lidocaine and its active metabolites were measured using validated ultra-performance liquid chromatography-tandem mass spectrometry. Safety was evaluated by monitoring and recording all adverse events (AEs). RESULTS: The concentrations of lidocaine were within the safe range, except one patient's concentration of lidocaine which reached the toxic range (> 5 mug/mL). The mean half-life (T(1/2)), the mean time to maximum observed concentration (T(max)), and the mean maximum observed concentration (C(max)) of lidocaine were 3.96 h, 2.85 h, and 2030 ng/mL, respectively; the mean T(1/2), T(max), and C(max) (n = 32) of MEGX were 6.59 h, 5.05 h, and 333.28 ng/mL, respectively; and the mean T(1/2), T(max), and C(max) of GX (n = 18) were 25.98 h, 7.33 h, and 75.81 ng/mL. Although eight subjects with AEs were reported, there were no serious AEs or deaths. No patients had serious postoperative complications. No deaths occurred within 30 days after the operation. CONCLUSIONS: Under the administration regimen of this study, intravenous infusion of lidocaine is safe and tolerable for liver cancer patients with laparoscopic hepatectomy. Fine safety and PK characteristics support the application of lidocaine in such patients and further clinical research. TRIAL REGISTRATION: China Clinical Trial Registration Center (ChiCTR2100042730), Registered 27 January 2021. CI - (c) 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature. FAU - He, Chaoqun AU - He C AD - Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, No. 1 Maoyuan South Road, Shunqing District, Nanchong, 637000, Sichuan Province, China. AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. AD - Department of Anesthesia, North Sichuan Medical College, Nanchong, 637000, China. FAU - Jin, Ying AU - Jin Y AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. FAU - Zhang, Yang AU - Zhang Y AD - Department of Anesthesia, North Sichuan Medical College, Nanchong, 637000, China. AD - Department of Anesthesiology, Suining Central Hospital, Suining, 629000, China. FAU - Zhang, Mengyu AU - Zhang M AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. FAU - Di, Xiangjie AU - Di X AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. FAU - Fu, Lisha AU - Fu L AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. FAU - Qi, Xiaohui AU - Qi X AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. FAU - Liu, Runhan AU - Liu R AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. FAU - Zheng, Li AU - Zheng L AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. FAU - Wang, Zhenlei AU - Wang Z AD - Department of Pharmacy, NMPA Key Laboratory for Clinical Research and Evaluation of Innovative Drug, West China Hospital, Sichuan University, No. 5 Telecom Road, Wuhou District, Chengdu, 610041, China. wangzhenlei@wchscu.cn. AD - Clinical Trial Center, West China Hospital, Sichuan University, Chengdu, 610041, China. wangzhenlei@wchscu.cn. FAU - Li, Jingdong AU - Li J AD - Department of Hepatocellular Surgery, Institute of Hepato-Biliary-Intestinal Disease, Affiliated Hospital of North Sichuan Medical College, No. 1 Maoyuan South Road, Shunqing District, Nanchong, 637000, Sichuan Province, China. lijingdong358@126.com. FAU - Tu, Faping AU - Tu F AD - Department of Anesthesiology, Affiliated Hospital of North Sichuan Medical College, No. 1 Maoyuan South Road, Shunqing District, Nanchong, 637000, Sichuan Province, China. tfpnc@163.com. AD - Department of Anesthesia, North Sichuan Medical College, Nanchong, 637000, China. tfpnc@163.com. LA - eng GR - 81903722/Youth Program of National Natural Science Foundation of China/ PT - Clinical Trial PT - Journal Article DEP - 20230419 PL - Germany TA - Eur J Clin Pharmacol JT - European journal of clinical pharmacology JID - 1256165 RN - 98PI200987 (Lidocaine) SB - IM MH - Humans MH - China MH - Chromatography, Liquid MH - *Lidocaine/adverse effects MH - *Liver Neoplasms/surgery OTO - NOTNLM OT - Intravenous OT - Laparoscopic hepatectomy OT - Lidocaine OT - Liver cancer OT - Pharmacokinetics OT - Safety EDAT- 2023/04/19 12:42 MHDA- 2023/06/01 06:42 CRDT- 2023/04/19 11:12 PHST- 2023/02/20 00:00 [received] PHST- 2023/04/12 00:00 [accepted] PHST- 2023/06/01 06:42 [medline] PHST- 2023/04/19 12:42 [pubmed] PHST- 2023/04/19 11:12 [entrez] AID - 10.1007/s00228-023-03498-0 [pii] AID - 10.1007/s00228-023-03498-0 [doi] PST - ppublish SO - Eur J Clin Pharmacol. 2023 Jun;79(6):829-839. doi: 10.1007/s00228-023-03498-0. Epub 2023 Apr 19.