Sedation in ICU Patients With Mechanical Ventilation

N/ANot Yet RecruitingNCT06538883

Zhongda Hospital366 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

366

Conditions

Respiration, Artificial Hypnotics and Sedatives

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria (patients who met all the following 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 (patients who met 1 of the following criteria were excluded): 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.

Outcomes

Primary Outcomes

The primary outcome is the rate of successful sedation without hypotension

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.

Time frame: within the first 30 minutes of administering the study drug

Secondary Outcomes

the rate of within sedation target (RASS: +1 to -2) without hypotension in the first 1hour of administering the study drug;

Time frame: within the first 1hour of administering the study 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;

Time frame: within the first 1hour of administering the study drug

Usage of study drugs

the total additional dose will be recorded;

Time frame: within the first 24hours of administering the study drug

Duration of mechanical ventilation

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;

Time frame: 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

Extubation time

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;

Time frame: from intubation (for patients intubated after ICU admission) or ICU admission (for patients admitted with intubation) to extubation

Awakening time

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;

Time frame: 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

Incidence of delirium

Incidence of delirium, which is assessed using the CAM-ICU;

Time frame: 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

Length of ICU stay

defined as the time from ICU admission to discharge from the ICU;

Time frame: the time from ICU admission to discharge from the ICU or death from any cause, whichever came first, assessed up to 28 days

The 28-day mortality

all caused mortality within 28 days.

Time frame: from administation of study drug to 28 days

Incidence of hypotension

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;

Time frame: from the time of signing informed consent to 2 hours after the end of study drug administration

Incidence of bradycardia

HR \< 40 bpm or a drop of more than 30% from baseline; the use of medications for bradycardia intervention