Ciprofol sedation in ICU patients
Trial question
Is ciprofol sedation noninferior to propofol sedation in ICU patients undergoing mechanical ventilation?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 133
133 patients (49 female, 84 male).
Inclusion criteria: ICU patients aged 18-80 years with endotracheal intubation and undergoing mechanical ventilation, who were expected to require sedation for 6-24 hours.
Key exclusion criteria: allergy/contraindications to propofol; opioids, and their antidotes; receipt of sedation for > 3 days before randomization; mental disorders; severe hepatic and renal insufficiency; pregnancy.
Interventions
N=88 ciprofol (intravenous infusion at a loading dose of 0.1 mg/kg and initial maintenance dose of 0.3 mg/kg/hr to achieve target sedation range of Richmond Agitation-Sedation Scale of +1 to -2).
N=45 propofol (intravenous infusion at a loading dose of 0.5 mg/kg and initial maintenance dose of 1.5 mg/kg/hr to achieve target sedation range of Richmond Agitation-Sedation Scale of +1 to -2).
Primary outcome
Successful sedation rate
97.7%
97.8%
97.8 %
73.3 %
48.9 %
24.4 %
0.0 %
Ciprofol
Propofol
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in successful sedation rate (97.7% vs. 97.8%; MD -0.05, 95% CI -5.98 to 9.44).
Secondary outcomes
Borderline significantly longer mean time to sedation (57.5 minutes vs. 57.7 minutes).
Significant increase in recovery time (4.8 minutes vs. 1.6 minutes; AD 3.2 minutes, 95% CI 1.09 to 5.31).
Borderline significant increase in mean sedation compliance rate (95.9% vs. 96.2%).
Safety outcomes
No significant difference in treatment-emergent adverse events or drug-related treatment-emergent adverse events.
Conclusion
In ICU patients aged 18-80 years with endotracheal intubation and undergoing mechanical ventilation, who were expected to require sedation for 6-24 hours, ciprofol was noninferior to propofol with respect to successful sedation rate.
Reference
Yongjun Liu, Zhiyong Peng, Songqiao Liu et al. Efficacy and Safety of Ciprofol Sedation in ICU Patients Undergoing Mechanical Ventilation: A Multicenter, Single-Blind, Randomized, Noninferiority Trial. Crit Care Med. 2023 Oct 1;51(10):1318-1327.
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