Intensive care medicine · 2026
Propofol versus ketamine in rapid sequence intubation in critically ill patients: a prospective, randomized, controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Schmidt Raysa Cristina, Godinho Zampieri Fernando, da Silva Ramos Fernando Jose, Santos Cavatoni Serra Felipe, Maccagnan Pinheiro Besen Bruno Adler, Fonseca Nunes Nathaly, Boschetti Daniela, Chohfi Atallah Fernanda, Jackiu Miriam, Garcia Melro Livia Maria, Nascimento Pontes Carla Daniele, Vieira Tomotani Daniere Yurie, Petri Damiani Lucas, Rezende de Freitas Flávio Geraldo, Ribeiro Machado Flávia, PROMINE Investigators
Аннотация
PURPOSE: The optimal hypnotic agent for rapid sequence intubation (RSI) in critically ill patients remains uncertain. We evaluated whether Ketamine is a better alternative than propofol.
METHODS: In this investigator-initiated, randomized, controlled, open-label trial conducted in two mixed ICU, adults (≥ 18 years) requiring RSI were assigned 1:1 to Ketamine or propofol. The primary outcome was the lowest mean arterial pressure (MAP) within the first 10 min after induction, analyzed with a linear regression model adjusted for age, baseline MAP, and total vasopressor dose within 10 min.
RESULTS: From October 2021 to October 2023, 207 patients were randomized and 175 were included in the modified intention-to-treat analysis. The lowest MAP within 10 min was 66 (55-79) mmHg with Ketamine and 60 (48-72) mmHg with propofol (mean difference, 6.0 [95% CI - 0.0 to 11.9]; p = 0.050). The average MAP difference over the first hour was 1.67 (95% CI - 1.98 to 5.31). Cardiovascular collapse occurred in 20/91(22%) Ketamine-treated patients and 28/84 (33%) receiving propofol, mainly due to an increase in the vasopressor dose within 2 min. Day-7 mortality was 33% with Ketamine and 23.8% with propofol (OR 1.38; 95% CI 0.86-2.24). Hospital mortality was 60.4% and 50.0%, respectively (OR 1.21; 95% CI 0.92-1.58).
CONCLUSIONS: Among critically ill patients undergoing RSI, Ketamine resulted in a less pronounced decrease in MAP in the first 10 min compared with propofol, but the difference was not clinically meaningful or sustained. These findings challenge sedative selection based solely on perceived risk of hypotension and highlight the need for larger trials to determine the optimal induction agent.
GOV REGISTRY: NCT05092152-initial release 10.13.2021.
METHODS: In this investigator-initiated, randomized, controlled, open-label trial conducted in two mixed ICU, adults (≥ 18 years) requiring RSI were assigned 1:1 to Ketamine or propofol. The primary outcome was the lowest mean arterial pressure (MAP) within the first 10 min after induction, analyzed with a linear regression model adjusted for age, baseline MAP, and total vasopressor dose within 10 min.
RESULTS: From October 2021 to October 2023, 207 patients were randomized and 175 were included in the modified intention-to-treat analysis. The lowest MAP within 10 min was 66 (55-79) mmHg with Ketamine and 60 (48-72) mmHg with propofol (mean difference, 6.0 [95% CI - 0.0 to 11.9]; p = 0.050). The average MAP difference over the first hour was 1.67 (95% CI - 1.98 to 5.31). Cardiovascular collapse occurred in 20/91(22%) Ketamine-treated patients and 28/84 (33%) receiving propofol, mainly due to an increase in the vasopressor dose within 2 min. Day-7 mortality was 33% with Ketamine and 23.8% with propofol (OR 1.38; 95% CI 0.86-2.24). Hospital mortality was 60.4% and 50.0%, respectively (OR 1.21; 95% CI 0.92-1.58).
CONCLUSIONS: Among critically ill patients undergoing RSI, Ketamine resulted in a less pronounced decrease in MAP in the first 10 min compared with propofol, but the difference was not clinically meaningful or sustained. These findings challenge sedative selection based solely on perceived risk of hypotension and highlight the need for larger trials to determine the optimal induction agent.
GOV REGISTRY: NCT05092152-initial release 10.13.2021.