Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial
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...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2024-10-01
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| Series: | Pain and Therapy |
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| Online Access: | https://doi.org/10.1007/s40122-024-00669-4 |
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| author | Jing-chao Luo Sen Lu Xi-liang Fu Jun Shen Hong-li He Chun Pan Xiao-bo Huang |
| author_facet | Jing-chao Luo Sen Lu Xi-liang Fu Jun Shen Hong-li He Chun Pan Xiao-bo Huang |
| author_sort | Jing-chao Luo |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-63f9478cc9004a8598cb2bc33136eba0 |
| institution | DOAJ |
| issn | 2193-8237 2193-651X |
| language | English |
| publishDate | 2024-10-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Pain and Therapy |
| spelling | doaj-art-63f9478cc9004a8598cb2bc33136eba02025-08-20T02:49:56ZengAdis, Springer HealthcarePain and Therapy2193-82372193-651X2024-10-011361695170410.1007/s40122-024-00669-4Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled TrialJing-chao Luo0Sen Lu1Xi-liang Fu2Jun Shen3Hong-li He4Chun Pan5Xiao-bo Huang6Department of Critical Care Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of ChinaDepartment of Critical Care Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of ChinaDepartment of Critical Care Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of ChinaDepartment of Critical Care Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of ChinaDepartment of Critical Care Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of ChinaDepartment of Critical Care Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of ChinaDepartment of Critical Care Medicine, Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of ChinaAbstract 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.https://doi.org/10.1007/s40122-024-00669-4OliceridineRemifentanilMechanical ventilationAnalgesiaICU |
| spellingShingle | Jing-chao Luo Sen Lu Xi-liang Fu Jun Shen Hong-li He Chun Pan Xiao-bo Huang Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial Pain and Therapy Oliceridine Remifentanil Mechanical ventilation Analgesia ICU |
| title | Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial |
| title_full | Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial |
| title_fullStr | Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial |
| title_full_unstemmed | Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial |
| title_short | Comparison of Oliceridine to Remifentanil for Optimal Analgesia in Mechanical Ventilation (CO-ROAM): Study Protocol for a Multicenter Randomized Controlled Trial |
| title_sort | comparison of oliceridine to remifentanil for optimal analgesia in mechanical ventilation co roam study protocol for a multicenter randomized controlled trial |
| topic | Oliceridine Remifentanil Mechanical ventilation Analgesia ICU |
| url | https://doi.org/10.1007/s40122-024-00669-4 |
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