Mao Junqin, Lin Kang, Liu Xiang, Liu Jie, Liang Gang, Jiang Chao, Sheng Zhimin
Department of Anesthesiology, Wenling Maternity and Child Health Care Hospital, 102, Xiabao Road, Chengdong Street Zhejiang Province, Taizhou, 317500, China.
Department of Anesthesiology, Wenling First People's Hospital (The Affiliated Wenling Hospital of Wenzhou Medical University), Zhejiang Province, Taizhou, China.
Trials. 2025 Oct 8;26(1):393. doi: 10.1186/s13063-025-09159-0.
Pediatric circumcision is a common yet often distressing procedure due to the associated pain and emotional response it can elicit in children. Adequate sedation and analgesia are critical to mitigate these effects and ensure the procedure's success. The combination of propofol and opioids continues to be the most commonly utilized intravenous anesthetic regimen for pediatric circumcision procedures. However, due to its narrow therapeutic index, propofol may cause notable hemodynamic and respiratory depression. Esketamine, an S(+)-isomer of ketamine, is recognized for its analgesic potency and minimal respiratory impact. Furthermore, its sympathomimetic properties offer a counterbalance to the hemodynamic inhibition of propofol. Therefore, the aim of this study is to determine the optimal dose of esketamine combined with propofol for pediatric circumcision.
This prospective, randomized controlled, dose-finding clinical trial will enroll 100 children aged 3-9 years who undergo circumcision. Participants will be randomly assigned to five groups to receive varying doses of esketamine (0.50, 0.75, 1.00, 1.25, and 1.50 mg/kg) combined with 3 mg/kg propofol for achieving adequate sedation. An effective dose of esketamine will be defined as non-occurrence of physical movement, frowning, or Ramsay Sedation Scale (RSS) score ≥ 5 during skin incision. The values for median effective dose (ED), 95% effective dose (ED), and 95% confidence intervals (95% CIs) of esketamine will be determined using probit regression.
The results of this study seek to determine the ED and ED values of esketamine combined with propofol for intravenous sedation in pediatric circumcision using probit regression analysis, which will provide further references for precise medication in pediatric circumcision.
Chinese Clinical Trial Registry ChiCTR2400090035. Registered on September 23, 2024.
小儿包皮环切术是一种常见但往往令人痛苦的手术，因为它会给儿童带来相关疼痛和情绪反应。充分的镇静和镇痛对于减轻这些影响并确保手术成功至关重要。丙泊酚和阿片类药物的组合仍然是小儿包皮环切术最常用的静脉麻醉方案。然而，由于其治疗指数狭窄，丙泊酚可能会引起明显的血流动力学和呼吸抑制。艾司氯胺酮是氯胺酮的S(+)异构体，以其镇痛效力和最小的呼吸影响而闻名。此外，其拟交感神经特性可抵消丙泊酚对血流动力学的抑制作用。因此，本研究的目的是确定艾司氯胺酮与丙泊酚联合用于小儿包皮环切术的最佳剂量。
这项前瞻性、随机对照、剂量探索性临床试验将招募100名年龄在3至9岁接受包皮环切术的儿童。参与者将被随机分配到五组，接受不同剂量的艾司氯胺酮（0.50、0.75、1.00、1.25和1.50mg/kg）与3mg/kg丙泊酚联合使用以实现充分镇静。艾司氯胺酮的有效剂量将定义为在皮肤切开期间无身体移动、皱眉或拉姆齐镇静评分（RSS）≥5。将使用概率回归确定艾司氯胺酮的中位有效剂量（ED）、95%有效剂量（ED）和95%置信区间（95%CI）值。
本研究结果旨在通过概率回归分析确定艾司氯胺酮与丙泊酚联合用于小儿包皮环切术静脉镇静的ED和ED值，这将为小儿包皮环切术的精确用药提供进一步参考。
中国临床试验注册中心ChiCTR2400090035。于2024年9月23日注册。
