Loading clinical trials...

Sedation in ICU Patients With Mechanical Ventilation | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

Sedation in ICU Patients With Mechanical Ventilation

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

NCT06538883•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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults are sequentially admitted to ICU undergoing mechanical ventilation; Patients are expected to need 6-24 hours of sedation for the target RASS ranged from +1 to -2 after randomization;
•2. Aged ≥ 18 and ≤ 80 years old, with no gender requirement;
•3. The patients or their family members fully understood the objectives and significance of this study and voluntarily participated and signed informed consent forms.

Exclusion Criteria

•1\. Patients known to be allergic or contraindicated to ciprofol. 2. BMI\<18 kg/m2 or \>30 kg/m2. 3. Patients who had received sedation for more than 3 days in an ICU or in a general ward prior to being transferred to the ICU before signing an informed consent form.
•4\. Patients have the following medical history or evidence of any of the following conditions at screening, which may increase the sedation/anesthesia risk:
•1. Cardiovascular system: New York Heart Association (NYHA) Class III and IV heart failure, Adams-stokes syndrome; patients who required vasopressor (equivalent norepinephrine ≥ 1μg/kg/min) to maintain a normal blood pressure.
•2. Patients with hepatic and renal failure (liver function: refer to Child-Pugh grade C; renal function: eGFR ≤ 30 mL/(min·1.73 m2) \[eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) equation: eGFR = 175 × serum creatinine (SCr) - 1.234 × age - 0.179 × 0.79 (females)\]; patients undergoing dialysis.
•3. Patients with grand mal epilepsy and convulsion; a Glasgow coma scale (GCS) ≤ 12 points.
•5\. Patients with an expected survival of ≤ 24 h. 6. Pregnant or lactating females. 7. Patients participated in other drug clinical trials before screening. 8. Other conditions that patients were judged by the investigator to be unsuitable for inclusion in the study.

Key Dates

Start Date

August 1, 2024

Primary Completion Date

June 30, 2026

Completion Date

July 30, 2026

Last Updated

August 6, 2024

Enrollment

366

ESTIMATED participants

Conditions

Respiration, ArtificialHypnotics and Sedatives

Interventions

Sedation with Ciprofol

DRUG

Sedation with Propofol

DRUG

Contacts

Fei Peng

CONTACT

15950565786 afei0312@163.com

A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score

NCT07098611

Ventilator WeaningRespiration, Artificial+6 more

View study

RECRUITINGNA

Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study

NCT06293976

Respiration, ArtificialReverse Triggering

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Sedation in ICU Patients With Mechanical Ventilation

Inclusion Criteria

Exclusion Criteria

A New Tool for Extubation Readiness in Mechanically Ventilated Patients: Readiness for EXtubation Score

Susceptibility for Entrainment: Role of Ventilator Settings on the Occurrence of Reverse Triggering and Its Physiological Consequences - the SEVeRe Study

Visualization of Inspiratory Effort and Respiratory Mechanics to Promote Lung- and Diaphragm Protective Ventilation

Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training

Impact of Decreasing Respiratory Rate on Lung Injury Biomarkers in ARDS Patients

Dexmedetomidine for Analgosedation to Newborn Infants During Neonatal Intensive Care