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IoC2监测与标准做法在减少接受腹腔镜结直肠手术老年患者阿片类药物消耗方面的比较:一项随机对照试验的研究方案

IoC2 monitoring versus standard practice in reducing opioid consumption in elderly patients undergoing laparoscopic colorectal surgery: a study protocol for a randomised controlled trial.

作者信息

Li Zhe, Cai Huamei, Yan Yun, Liu Xiaowen, Zhao Jing

机构信息

China-Japan Friendship Hospital, Beijing, Beijing, China.

Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, Beijing, China.

出版信息

BMJ Open. 2025 Jan 21;15(1):e093322. doi: 10.1136/bmjopen-2024-093322.

Abstract

INTRODUCTION

Nociception monitoring has recently gained recognition as a valuable tool for guiding intraoperative opioid administration. Several nociception monitors, including the Surgical Pleth Index, the Index of Consciousness (IoC) and the Nociception Level, have been introduced for managing intraoperative analgesia. While these technologies show promise in initial applications, the effectiveness of IoC2 in guiding pain management during anaesthesia, particularly in elderly patients who require precise opioid use, remains unclear. This study aims to evaluate the effectiveness of IoC2 in guiding intraoperative opioid use in elderly patients.

METHODS AND ANALYSIS

We will conduct a prospective, randomised, controlled, single-blind, single-centre study with recruitment carried out from 1 February to 30 November 2025. Patients will be randomly assigned to either the IoC2 group or the control group. In the IoC2 group, sufentanil dosing will be guided by intraoperative IoC2 measurements, while in the control group, it will be guided by haemodynamic parameters. The primary outcome will be to compare intraoperative sufentanil consumption between the two groups to assess the potential role of IoC2 in optimising perioperative analgesia in elderly patients.

ETHICS AND DISSEMINATION

This study has been approved by the ethics committee of China-Japan Friendship Hospital (2024-KY-148-3) and registered in the Chinese Clinical Trial Registry (ChiCTR2400089115). The findings will be disseminated through academic presentations and peer-reviewed journal publications, providing valuable data and insights into the role of IoC2 in guiding intraoperative pain management.

TRIAL REGISTRATION NUMBER

ChiCTR2400089115.

摘要

引言

伤害性感受监测最近已成为指导术中阿片类药物给药的一种有价值的工具。已经引入了几种伤害性感受监测仪,包括外科多谱指数、意识指数(IoC)和伤害性感受水平,用于管理术中镇痛。虽然这些技术在初始应用中显示出前景,但IoC2在麻醉期间指导疼痛管理的有效性,特别是在需要精确使用阿片类药物的老年患者中,仍不明确。本研究旨在评估IoC2在指导老年患者术中使用阿片类药物方面的有效性。

方法与分析

我们将进行一项前瞻性、随机、对照、单盲、单中心研究,招募时间为2025年2月1日至11月30日。患者将被随机分配到IoC2组或对照组。在IoC2组中,舒芬太尼的给药将根据术中IoC2测量结果进行指导,而在对照组中,将根据血流动力学参数进行指导。主要结果将是比较两组术中舒芬太尼的消耗量,以评估IoC2在优化老年患者围手术期镇痛方面的潜在作用。

伦理与传播

本研究已获得中日友好医院伦理委员会批准(2024-KY-148-3),并在中国临床试验注册中心注册(ChiCTR2400089115)。研究结果将通过学术报告和同行评审的期刊出版物进行传播,为IoC2在指导术中疼痛管理中的作用提供有价值的数据和见解。

试验注册号

ChiCTR2400089115。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54e9/11784178/8a767fa4be48/bmjopen-15-1-g001.jpg

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