Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial.

IF 4.1 2区 医学 Q1 CLINICAL NEUROLOGY
Pain and Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-18 DOI:10.1007/s40122-024-00669-4
Jing-Chao Luo, Sen Lu, Xi-Liang Fu, Jun Shen, Hong-Li He, Chun Pan, Xiao-Bo Huang
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引用次数: 0

Abstract

Introduction: Critically ill patients often endure pain, a distressing experience that can trigger diverse pathophysiological consequences. While remifentanil, with its rapid kinetics, is commonly used for analgesia in intensive care units (ICU), it frequently leads to opioid-related adverse effects. A promising alternative has emerged in oliceridine, a novel G protein-biased μ-opioid receptor agonist. This new drug offers the potential for effective pain relief with fewer side effects. However, its efficacy and safety profile in mechanically ventilated ICU patients remain to be fully elucidated.

Methods: This is a multicenter, prospective, randomized, single-blind, active-controlled trial conducted across 24 ICUs in China. A total of 292 mechanically ventilated patients requiring analgesia and sedation will be randomly assigned in a 1:1 ratio to either the oliceridine or remifentanil group. The oliceridine group will receive oliceridine (2-20 μg/kg/h), while the remifentanil group will receive remifentanil (1.5-12 μg/kg/h). Both groups will receive propofol for sedation if necessary. The target for analgesia is Critical-Care Pain Observation Tool (CPOT) < 3, and for sedation is Richmond Agitation-Sedation Scale (RASS) - 2 to 0.

Planned outcomes: The primary outcome will be the percentage of time within target analgesia during study drug administration. Secondary outcomes will include gastrointestinal dysfunction, respiratory depression, sedative usage, mechanical ventilation duration, ICU stay length, extubation failure rate, etc. TRIAL REGISTRATION: NCT06454292. Registered on June 11, 2024.

比较奥利司定和雷米芬太尼在机械通气中的最佳镇痛效果 (CO-ROAM):多中心随机对照试验研究方案》。
引言:重症患者经常忍受疼痛,这种痛苦的经历会引发多种病理生理后果。瑞芬太尼具有快速的动力学特性,常用于重症监护室(ICU)的镇痛,但经常会导致与阿片类药物相关的不良反应。奥利司定是一种新型的基于 G 蛋白的 μ 阿片受体激动剂,是一种很有前途的替代药物。这种新药可有效缓解疼痛,且副作用较少。然而,该药对机械通气 ICU 患者的疗效和安全性仍有待全面阐明:这是一项多中心、前瞻性、随机、单盲、主动对照试验,在中国的 24 家重症监护病房进行。共有 292 名需要镇痛和镇静的机械通气患者将按 1:1 的比例随机分配到奥利司定组或瑞芬太尼组。奥利司定组将接受奥利司定(2-20 μg/kg/h),而瑞芬太尼组将接受瑞芬太尼(1.5-12 μg/kg/h)。如有必要,两组患者都将接受异丙酚镇静。镇痛目标为危重症疼痛观察工具(CPOT)计划结果:主要结果是研究用药期间达到目标镇痛时间的百分比。次要结果包括胃肠道功能障碍、呼吸抑制、镇静剂使用、机械通气持续时间、重症监护室住院时间、拔管失败率等。试验注册:NCT06454292。注册日期:2024 年 6 月 11 日。
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来源期刊
Pain and Therapy
Pain and Therapy CLINICAL NEUROLOGY-
CiteScore
6.60
自引率
5.00%
发文量
110
审稿时长
6 weeks
期刊介绍: Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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