TOPLINE:

In ICU patients on mechanical ventilation, mostly after surgery, remimazolam tosylate was noninferior to propofol for sedation. The two agents had a comparable incidence of adverse events.

METHODOLOGY:

• Researchers conducted a randomized controlled phase 3 trial across 29 medical centers in China between March and September 2024 to assess the efficacy and safety of remimazolam tosylate vs propofol for sedation in the ICU setting.
• They enrolled 211 adult patients on mechanical ventilation in the ICU (mean age, 61.1 years; 63.5% men; 99.1% admitted post-surgery) who required sedation for at least 6 hours, with a target Richmond Agitation-Sedation Scale (RASS) score of -2 to +1 and BMI of 18-30.
• Patients were randomly assigned to receive either remimazolam tosylate (n = 106; loading dose 0.08 mg/kg followed by continuous infusion at 0.2 mg/kg/h) or propofol (n = 105; loading dose 0.3-0.5 mg/kg followed by continuous infusion at 0.3 mg/kg/h), with additional boluses given as needed, for up to 24 hours.
• The primary endpoint was the proportion of patients achieving sedation success, defined as maintaining the target RASS score for 70% or more of the total drug administration time without the use of rescue sedation; noninferiority was established if the lower limit of the 95% CI for the difference exceeded -8%.
• The secondary endpoints included the percentage of time within the target sedation range, the number of additional boluses required, time from stopping the drug to full wakefulness, and other variables.

TAKEAWAY:

• The sedation success rate was 98.1% in the remimazolam tosylate group vs 96.2% in the propofol group, with a between-group difference of 1.9% (95% CI, -3.3% to 7.8%), demonstrating noninferiority as the lower limit of the 95% CI exceeded the predefined margin of -8%.
• The mean percentage of time within the target RASS range was comparable between the remimazolam tosylate and propofol groups (95.1% vs 95.0%), with no patients in the remimazolam group requiring rescue sedation compared with 1.0% of patients in the propofol group.
• The remimazolam tosylate group received treatment for a mean of 11.5 hours, and the propofol group received it for a mean of 11.1 hours, with mean total doses of 187.1 mg and 593.7 mg, respectively. The mean time to full wakefulness was longer in the remimazolam group than in the propofol group (11.8 vs 4.1 minutes; P =.023).
• The overall incidence of adverse events (76.4% vs 73.3%) and that of treatment-related adverse events (28.3% vs 23.8%) were comparable between the groups, with most events being mild or moderate; one severe case (anemia) was noted in the propofol group, and one serious adverse event (acute kidney injury) occurred in the remimazolam tosylate group.

IN PRACTICE:

The findings "provide robust evidence supporting the noninferiority of remimazolam tosylate compared to propofol for sedation efficacy in mechanically ventilated ICU patients, confirming and extending findings from previous smaller and predominantly single-center studies," the researchers reported.

SOURCE:

The study was led by Xiangdong Guan, PhD, and Ning Liu, MD, of the Department of Critical Care Medicine at The First Affiliated Hospital of Sun Yat-sen University in Guangzhou, China. It was published online March 19, 2026, in Anesthesiology.

LIMITATIONS: 

The personnel who prepared and administered the drugs could not be kept unaware of the treatment. Remimazolam tosylate was evaluated for a short period of up to 24 hours. The study did not collect information on the duration of invasive mechanical ventilation and exposure to sedation before enrollment.

DISCLOSURES:

This study was sponsored by Jiangsu Hengrui Pharmaceuticals and partly supported by the Guangdong Clinical Research Center for Critical Care Medicine. Four authors disclosed being employees of Jiangsu Hengrui Pharmaceuticals.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.