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NOT YET RECRUITING
NCT06538883
NA

Sedation in ICU Patients With Mechanical Ventilation

Sponsor: Zhongda Hospital

View on ClinicalTrials.gov

Summary

Sedatives are the mostly common prescription for patients with mechanical ventilation due to the disease or therapies. Ciprofol is a new intravenous anesthetic agent transformed from propofol, and has a similar sedative effect of propofol in previous study. Whether ciprofol is safe and effective similar with propofol for sedation in ICU patients with mechanical ventilation? Therefor, a multi-center, double-blind, randomized control trial was conducted with a noninferiority design, to compared the rate of successful sedation without hypotension of sedation by ciprofol or propofol in ICU patients with mechanical ventilation. A Multi-Center, Double-Blind, Randomized Controlled Trial will be launched to evaluate the efficacy and safety of ciprofol versus propofol for sedation in ICU patients with mechanical ventilation.

Official title: Efficacy and Safety of Ciprofol Versus Propofol for Sedation in ICU Patients With Mechanical Ventilation: A Multi-Center, Double-Blind, Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

366

Start Date

2024-08-01

Completion Date

2026-07-30

Last Updated

2024-08-06

Healthy Volunteers

No

Interventions

DRUG

Sedation with Ciprofol

During the drug administration period, ciprofol were IV infused at loading doses of 0.1 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Ciprofol were then immediately administered at an initial maintenance dose of 0.3 mg/kg/hr, with a target sedation depth of RASS +1 to -2, based on the Pain, Agitation/sedation, Delirium, Immobility (rehabilitation/mobilization), and Sleep (disruption) guideline.

DRUG

Sedation with Propofol

During the drug administration period, propofol were IV infused at loading doses of 0.5 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Propofol were then immediately administered at an initial maintenance dose of 1.5 mg/kg/hr, with a target sedation depth of RASS +1 to -2, based on the Pain, Agitation/sedation, Delirium, Immobility (rehabilitation/mobilization), and Sleep (disruption) guideline.