Remi-fent 1-A pragmatic randomised controlled study to evaluate the feasibility of using remifentanil or fentanyl as sedation adjuncts in mechanically ventilated patients
© 2023 The Authors..
Objective: To evaluate the feasibility of conducting a prospective randomised controlled trial (pRCT) comparing remifentanil and fentanyl as adjuncts to sedate mechanically ventilated patients.
Design: Single-center, open-labelled, pRCT with blinded analysis.
Setting: Australian tertiary intensive care unit (ICU).
Participants: Consecutive adults between June 2020 and August 2021 expected to receive invasive ventilation beyond the next day and requiring opioid infusion were included. Exclusion criteria were pregnant/lactating women, intubation >12 h, or study-drug hypersensitivity.
Interventions: Open-label fentanyl and remifentanil infusions per existing ICU protocols.
Outcomes: Primary outcomes were feasibility of recruiting ≥1 patient/week and >90 % compliance, namely no other opioid infusion used during the study period. Secondary outcomes included complications, ICU-, ventilator- and hospital-free days, and mortality (ICU, hospital). Blinded intention-to-treat analysis was performed concealing the allocation group.
Results: 208 patients were enrolled (mean 3.7 patients/week). Compliance was 80.6 %. More patients developed complications with fentanyl than remifentanil: bradycardia (n = 44 versus n = 21; p < 0.001); hypotension (n = 78 versus n = 53; p < 0.01); delirium (n = 28 versus n = 15; p = 0.001). No differences were seen in ICU (24.3 % versus 27.6 %,p = 0.60) and hospital mortalities (26.2 % versus 30.5 %; p = 0.50). Ventilator-free days were higher with remifentanil (p = 0.01).
Conclusions: We demonstrated the feasibility of enrolling patients for a pRCT comparing remifentanil and fentanyl as sedation adjuncts in mechanically ventilated patients. We failed to attain the study-opioid compliance target, likely because of patients with complex sedative/analgesic requirements. Secondary outcomes suggest that remifentanil may reduce mechanical ventilation duration and decrease the incidence of complications. An adequately powered multicentric phase 2 study is required to evaluate these results.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:25 |
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| Enthalten in: |
Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine - 25(2023), 4 vom: 16. Dez., Seite 216-222 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rajamani, Arvind [VerfasserIn] |
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| Links: |
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| Themen: |
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| Anmerkungen: |
Date Revised 19.01.2024 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.ccrj.2023.10.012 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM367248395 |
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| 100 | 1 | |a Rajamani, Arvind |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Remi-fent 1-A pragmatic randomised controlled study to evaluate the feasibility of using remifentanil or fentanyl as sedation adjuncts in mechanically ventilated patients |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Revised 19.01.2024 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2023 The Authors. | ||
| 520 | |a Objective: To evaluate the feasibility of conducting a prospective randomised controlled trial (pRCT) comparing remifentanil and fentanyl as adjuncts to sedate mechanically ventilated patients | ||
| 520 | |a Design: Single-center, open-labelled, pRCT with blinded analysis | ||
| 520 | |a Setting: Australian tertiary intensive care unit (ICU) | ||
| 520 | |a Participants: Consecutive adults between June 2020 and August 2021 expected to receive invasive ventilation beyond the next day and requiring opioid infusion were included. Exclusion criteria were pregnant/lactating women, intubation >12 h, or study-drug hypersensitivity | ||
| 520 | |a Interventions: Open-label fentanyl and remifentanil infusions per existing ICU protocols | ||
| 520 | |a Outcomes: Primary outcomes were feasibility of recruiting ≥1 patient/week and >90 % compliance, namely no other opioid infusion used during the study period. Secondary outcomes included complications, ICU-, ventilator- and hospital-free days, and mortality (ICU, hospital). Blinded intention-to-treat analysis was performed concealing the allocation group | ||
| 520 | |a Results: 208 patients were enrolled (mean 3.7 patients/week). Compliance was 80.6 %. More patients developed complications with fentanyl than remifentanil: bradycardia (n = 44 versus n = 21; p < 0.001); hypotension (n = 78 versus n = 53; p < 0.01); delirium (n = 28 versus n = 15; p = 0.001). No differences were seen in ICU (24.3 % versus 27.6 %,p = 0.60) and hospital mortalities (26.2 % versus 30.5 %; p = 0.50). Ventilator-free days were higher with remifentanil (p = 0.01) | ||
| 520 | |a Conclusions: We demonstrated the feasibility of enrolling patients for a pRCT comparing remifentanil and fentanyl as sedation adjuncts in mechanically ventilated patients. We failed to attain the study-opioid compliance target, likely because of patients with complex sedative/analgesic requirements. Secondary outcomes suggest that remifentanil may reduce mechanical ventilation duration and decrease the incidence of complications. An adequately powered multicentric phase 2 study is required to evaluate these results | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Feasibility | |
| 650 | 4 | |a Fentanyl | |
| 650 | 4 | |a ICU | |
| 650 | 4 | |a Remifentanil | |
| 650 | 4 | |a Safety | |
| 700 | 1 | |a Subramaniam, Ashwin |e verfasserin |4 aut | |
| 700 | 1 | |a Lung, Brian |e verfasserin |4 aut | |
| 700 | 1 | |a Masters, Kristy |e verfasserin |4 aut | |
| 700 | 1 | |a Gresham, Rebecca |e verfasserin |4 aut | |
| 700 | 1 | |a Whitehead, Christina |e verfasserin |4 aut | |
| 700 | 1 | |a Lowrey, Julie |e verfasserin |4 aut | |
| 700 | 1 | |a Seppelt, Ian |e verfasserin |4 aut | |
| 700 | 1 | |a Kumar, Hemant |e verfasserin |4 aut | |
| 700 | 1 | |a Kumar, Jayashree |e verfasserin |4 aut | |
| 700 | 1 | |a Hassan, Anwar |e verfasserin |4 aut | |
| 700 | 1 | |a Orde, Sam |e verfasserin |4 aut | |
| 700 | 1 | |a Bharadwaj, Pranav Arun |e verfasserin |4 aut | |
| 700 | 1 | |a Arvind, Hemamalini |e verfasserin |4 aut | |
| 700 | 1 | |a Huang, Stephen |e verfasserin |4 aut | |
| 700 | 0 | |a SPARTAN Collaborative |e verfasserin |4 aut | |
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