奥利维定用于术后疼痛和阿片类药物相关并发症：静脉注射奥利维定和阿片类药物相关并发症（VOLITION）前瞻性队列研究

IF 5 2区医学 Q1 ANESTHESIOLOGY

Journal of Clinical Anesthesia Pub Date : 2025-05-29 DOI:10.1016/j.jclinane.2025.111870

Daniel I. Sessler MD , Sabry Ayad MD , Omer Bakal MD , Nataya S. Disher BS , Jorge Araujo Duran MD , Toby N. Weingarten MD , Albert Dahan MD, PhD , Mark A. Demitrack MD , Jessica Kim MS , Ashish K. Khanna MD, MS , the VOLITION Study Team

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引用次数: 0

摘要

甘草定是一种G蛋白选择性μ-阿片受体激动剂，具有降低β-抑制素激活的作用，与传统的阿片药物相比，可能产生更少的阿片相关不良反应（orae）。VOLITION前瞻性队列研究评估了奥利匹啶对术后疼痛的治疗效果，并评估了orae。方法纳入204例计划行非心脏大手术的患者。我们的主要目的是量化术后最初两天出现呼吸损害的患者比例。用脉搏血氧仪、血流描记仪和脉搏体积描记仪连续监测心肺功能。我们的临床有意义的呼吸事件组合定义为：末潮（Et） CO2≤15mmhg≥3分钟，呼吸频率≤5次/分钟≥3分钟，氧饱和度≤85%≥3分钟，呼吸暂停持续30秒，或任何危及生命的呼吸事件。所有潜在的呼吸事件由两名独立的专家评审。在探索性的基础上，我们评估了达到完全胃肠道反应（无呕吐和无抢救止吐药使用）的患者比例。采用Richmond激动-镇静量表、Pasero阿片类药物诱导镇静量表和3分钟诊断混淆评估法评估中枢神经系统损害。结果203例安全人群(平均年龄57岁，52%为女性；平均手术时间：5小时)，197例患者有可用于分析的心肺数据。胆碱的中位累积剂量为33 mg （1.5-75 mg）。45例患者（23%）中有174例确诊的呼吸损害发作，但没有死亡或与胆碱相关的严重不良事件。从未需要纳洛酮类阿片逆转。107例（53%）患者有完全的胃肠道反应，其中8例符合谵妄的筛查标准。结论近1 / 4的患者使用奥利胆碱镇痛后出现呼吸损伤，且无生命危险。需要一项随机试验来确定橄榄苷是否比传统阿片类药物产生更少的总体orae。该研究已在ClinicalTrials.gov注册（NCT04979247）。

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Oliceridine for postoperative pain and opioid-related complications: The intravenous oliceridine and opioid-related complications (VOLITION) prospective cohort study

Background

Oliceridine is a G protein-selective μ-opioid receptor agonist with reduced β-arrestin activation that may produce fewer opioid-related adverse effects (ORAEs) than traditional opioids. The VOLITION prospective cohort study evaluated oliceridine for management of postoperative pain and evaluated ORAEs.

Methods

We enrolled 204 patients scheduled for major noncardiac surgery. Our primary aim was to quantify the proportion of patients having respiratory compromise over the initial two postoperative days. Cardiorespiratory function was continuously monitored with pulse oximetry, capnography, and plethysmography. Our composite of clinically meaningful respiratory events was defined by an end-tidal (Et) CO₂ ≤ 15 mmHg for ≥3 min, respiratory rate ≤ 5 breaths/min for ≥3 min, oxygen saturation ≤ 85 % for ≥3 min, apnea lasting >30 s, or any life-threatening respiratory events. All potential respiratory events were adjudicated by two independent expert reviewers. On an exploratory basis we evaluated the proportion of patients achieving a complete gastrointestinal response (no vomiting and no rescue antiemetic use). Central nervous system compromise was evaluated with the Richmond Agitation-Sedation Scale, the Pasero Opioid-Induced Sedation Scale, and the 3-min Diagnostic Confusion Assessment Method.

Results

Among 203 patients in the safety population (mean age 57 years, 52 % women; mean duration of surgery: 5 h), 197 patients had cardiorespiratory data available for analysis. The median cumulative oliceridine dose was 33 mg (range 1.5–75 mg). There were 174 adjudicated episodes of respiratory compromise in 45 patients (23 %) but no deaths or oliceridine-related serious adverse events. Naloxone opioid reversal was never required. There were 107 (53 %) patients who had a complete gastrointestinal response, and eight met screening criteria for delirium.

Conclusion

Nearly one quarter of patients experienced a respiratory compromise with oliceridine analgesia, none of which was life-threatening. A randomized trial needs to determine whether oliceridine produces fewer overall ORAEs than conventional opioids.

The study was registered at ClinicalTrials.gov (NCT04979247).

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来源期刊

Journal of Clinical Anesthesia 医学-麻醉学

CiteScore

7.40

自引率

4.50%

发文量

346

审稿时长

23 days

期刊介绍： The Journal of Clinical Anesthesia (JCA) addresses all aspects of anesthesia practice, including anesthetic administration, pharmacokinetics, preoperative and postoperative considerations, coexisting disease and other complicating factors, cost issues, and similar concerns anesthesiologists contend with daily. Exceptionally high standards of presentation and accuracy are maintained. The core of the journal is original contributions on subjects relevant to clinical practice, and rigorously peer-reviewed. Highly respected international experts have joined together to form the Editorial Board, sharing their years of experience and clinical expertise. Specialized section editors cover the various subspecialties within the field. To keep your practical clinical skills current, the journal bridges the gap between the laboratory and the clinical practice of anesthesiology and critical care to clarify how new insights can improve daily practice.