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

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

Recruiting
18-64 years
All
Phase 4

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Overview

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.

Eligibility

Inclusion Criteria:

  • 18-64 years old
  • must accept no-cardiac elective surgery
  • must under general anaesthesia
  • can be combined regional tissue anesthesia
  • must admitted to ICU with tracheal intubation after general anaesthesia - expected mechanical ventilation time must more than 24 hours
  • light or moderate sedation must needed

Exclusion Criteria:

  • intracranial surgery or severe neurological or spinal cord disease
  • schizophrenia, epilepsy, and 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 24 hours before or during surgery
  • pregnancy or lactation
  • any investigational drug useage 30 days before surgery
  • refuse to participant.

Study details
    Effect of Drug
    Adverse Drug Event
    Mechanical Ventilation Complication
    Critical Illness
    Surgery
    Sedation

NCT06575530

Beijing Shijitan Hospital, Capital Medical University

15 October 2025

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