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Long-term Sedation Effect of Ciprofol Compared to Dexmedetomidine in Patients With Invasive Mechanical Ventilation: A Multicenter, Randomized, Open, Parallel-controlled Study

Long-term Sedation Effect of Ciprofol Compared to Dexmedetomidine in Patients With Invasive Mechanical Ventilation: A Multicenter, Randomized, Open, Parallel-controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078671
Enrollment
Unknown
Registered
2023-12-14
Start date
2023-03-08
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Mechanical Ventilation

Interventions

Dexmedetomidine group:Drug: Dexmedetomidine
Ciprofol group:Drug: Ciprofol

Sponsors

The first people’s hospital of Changzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients with an endotracheal intubation duration of =96 hours before enrollment 2.Patients with an anticipated mechanical ventilation duration of = 24 h 3.Patients with an anticipated sedation duration of = 24 h 4.Target RASS score -2 to +1 5.Age, =18 and <80 years, no gender limit, BMI =30 kg/m2

Exclusion criteria

Exclusion criteria: 1.Patients who are allergic to the study drugs, or patients with contraindications to the study drugs 2.Severe neurological disease or other medical conditions that makes it unable to give RASS score(Expected to require major surgery during ICU hospitalization) 3.Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion. 4.Heart rate less than 50/min 5.second- or third- degree heart block (Patients with implanted pacemakers may not be excluded) 6.unstable angina pectoris or myocardial infarction 7.Patients with a moribund state and patients with an anticipated death in ICU 8.acute hepatitis or severe liver disease (Child-Pugh class C) 9.Patients who need neuromuscular blockers to promote mechanical ventilation 10.Patients who are unlikely to be taken off from mechanical ventilation 11.Patient is pregnant and/or lactating 12.Subject judged by the investigator to have any other factors unsuitable for participation in the study

Design outcomes

Primary

MeasureTime frame
the proportion of time in target sedation range (RASS score, -2 to +1);the propotion and the duration of bradycardia and hypotension;

Secondary

MeasureTime frame
Mean time within the target RASS range;Success rate of sedation;Recovery time;Median time of mechanical ventilation/Median time to extubation;28-day mechanical ventilation-free days;the total times of dose adjustments;Vital sign;Adverse events;ICU-LOS;28-day all-cause mortality;

Countries

China

Contacts

Public ContactDaming Wang

The first people’s hospital of Changzhou

wangdamingicu@163.com+86 139 0612 5600

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 1, 2026