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Open Access 18-10-2024 | Remifentanil | STUDY PROTOCOL

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

Authors: Jing-chao Luo, Sen Lu, Xi-liang Fu, Jun Shen, Hong-li He, Chun Pan, Xiao-bo Huang

Published in: Pain and Therapy | Issue 6/2024

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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.
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Metadata
Title
Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial
Authors
Jing-chao Luo
Sen Lu
Xi-liang Fu
Jun Shen
Hong-li He
Chun Pan
Xiao-bo Huang
Publication date
18-10-2024
Publisher
Springer Healthcare
Published in
Pain and Therapy / Issue 6/2024
Print ISSN: 2193-8237
Electronic ISSN: 2193-651X
DOI
https://doi.org/10.1007/s40122-024-00669-4

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