Sedation in ICU Patients With Mechanical Ventilation

Not Applicable

Not yet recruiting

• Conditions: Hypnotics and Sedatives; Respiration, Artificial
• Interventions: Drug: Sedation with Ciprofol; Drug: Sedation with Propofol

• Registration Number: NCT06538883
• Lead Sponsor: Zhongda Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-04
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Study First Submitted QC: 2024-08-05
• Last Update Submitted: 2024-08-05
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06
• Primary Completion: 2026-06-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 366

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofol	Sedation with Ciprofol	-
Propofol	Sedation with Propofol	-

Primary Outcome Measures

Name	Time	Method
The primary outcome is the rate of successful sedation without hypotension	within the first 30 minutes of administering the study drug	The primary outcome is the rate of successful sedation without hypotension, which have to meet the following three criteria simultaneously: 1) Sedation within the RASS target (+1 to -2); 2) No rescue therapy is used; 3) No hypotension occurs, within the first 30 minutes of administering the study drug.

Secondary Outcome Measures

Name	Time	Method
The 28-day mortality	from administation of study drug to 28 days	all caused mortality within 28 days.
Incidence of hypotension	from the time of signing informed consent to 2 hours after the end of study drug administration	Hypotension was defined as SBP \< 90 mmHg, or DBP \< 60 mmHg, or MAP \< 70 mmHg, or a drop of more than 30% from baseline, more than 2 minutes, or as determined by the investigator; and the use of vasopressor medications will be recorded;
Incidence of bradycardia	from the time of signing informed consent to 2 hours after the end of study drug administration	HR \< 40 bpm or a drop of more than 30% from baseline; the use of medications for bradycardia intervention
Usage of study drugs	within the first 24hours of administering the study drug	the total additional dose will be recorded;
the rate of within sedation target (RASS: +1 to -2) without hypotension in the first 1hour of administering the study drug;	within the first 1hour of administering the study drug
Extubation time	from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) to extubation	time from stopping the study drug to extubation; not applicable for patients who withdraw early or do not plan to extubate after stopping the drug;
the rate of within sedation target (RASS: +1 to -2) without circulatory inhibition (defined as either hypotension or bradycardia) in the first 1hour of administering the study drug;	within the first 1hour of administering the study drug
Duration of mechanical ventilation	from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) until the date of first estubation or date of death from any cause, whichever came first, assessed up to 28 days	Duration of mechanical ventilation: defined as the time from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) to extubation;
Awakening time	from stopping the study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 28 days	defined as the time from stopping the study drug to awakening from sedation (RASS ≥ 0). If RASS is ≥ 0 at the time of stopping the drug, the awakening time is recorded as 0;
Incidence of delirium	from administation of study drug until the time of awakening from sedation (RASS ≥ 0) or death from any cause, whichever came first, assessed up to 28 days	Incidence of delirium, which is assessed using the CAM-ICU;
Length of ICU stay	the time from ICU admission to discharge from the ICU or death from any cause, whichever came first, assessed up to 28 days	defined as the time from ICU admission to discharge from the ICU;