Actively Recruiting

Phase 4
Age: 18Years - 64Years
All Genders
NCT06575530

Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients

Led by Beijing Shijitan Hospital, Capital Medical University · Updated on 2026-01-07

306

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A multi-center, prospective, randomized, double-blind, no-inferiority clinical trial designed to assess the the safety and efficacy of remazolam besylate in sedation of critically ill mechanically ventilated patients after surgery compared to dexmedetomidine.

CONDITIONS

Official Title

Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 to 64 years old
  • Undergoing non-cardiac elective surgery
  • Received general anesthesia
  • May have combined regional tissue anesthesia
  • Admitted to ICU with tracheal intubation after general anesthesia
  • Expected mechanical ventilation time more than 24 hours
  • Requires light or moderate sedation
Not Eligible

You will not qualify if you...

  • History of intracranial surgery or severe neurological or spinal cord disease
  • Diagnosis of schizophrenia, epilepsy, or Parkinson's disease
  • Coma, severe dementia, or language barrier before surgery
  • Cardiac dysfunction or arrhythmia
  • Severe liver dysfunction (Child-Pugh C class)
  • Severe kidney dysfunction
  • Use of dexmedetomidine or remifentanil besylate within 24 hours before or during surgery
  • Pregnancy or lactation
  • Use of any investigational drug within 30 days before surgery
  • Refusal to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Shijitan Hospital.CMU

Beijing, Beijing Municipality, China, 100038

Actively Recruiting

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Research Team

Y

Yuefu Wang, doctor

CONTACT

D

Dandan Liu, master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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