Sedation in ICU Patients With Mechanical Ventilation

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.

Conditions

• Sedation
• Mechanical Ventilation

Interventions

DRUG

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Air Force Medicial University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Zhongnan University Xiangya Second Hospital

  collaborator UNKNOWN

• Renmin Hospital of Wuhan University

  collaborator OTHER

• First Affiliated Hospital of Suzhou Medical College

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Zhongnan Hospital

  collaborator OTHER

• First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital)

  collaborator UNKNOWN

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Sichuan Academy of Medical Sciences

  collaborator OTHER

• Anhui provincial chest hospital

  collaborator UNKNOWN

• The Guangxi Zhuang Autonomous Region People's Hospital

  collaborator UNKNOWN

• Second Affiliated Hospital of Suzhou University

  collaborator OTHER

• The Ninth People's Hospital of Suzhou

  collaborator UNKNOWN

• Fifth Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Xuzhou Medical University Hospital

  collaborator UNKNOWN

• First People's Hospital of Hangzhou

  collaborator OTHER

• Hebei Medical University Fourth Hospital

  collaborator OTHER

• Huai'an First People's Hospital

  collaborator OTHER

• Jinan City People's Hospital

  collaborator UNKNOWN

• The First People's Hospital of Lianyungang

  collaborator OTHER

• Jiangsu Subei People's Hospital

  collaborator UNKNOWN

• Suqian First Hospital

  collaborator OTHER

• Taian City Central Hospital

  collaborator OTHER

• Xuzhou Central Hospital

  collaborator OTHER

• The first People's Hospital of Yancheng City

  collaborator UNKNOWN

• The First People's Hospital of Zunyi

  collaborator OTHER

• Jiangxi Provincial People's Hopital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Zhongda Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2026-06-30

Completion

2026-07-30

Countries

• China

Study Locations