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

Phase

Condition

Anesthesia

Surgery

Treatment

Remimazolam Besylate

Dexmedetomidine Hydrochloride

sedation drug

Clinical Study ID

NCT06575530

IIT2024-001-002

Ages 18-64
All Genders

Study Summary

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 Criteria

Inclusion

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 - expectedmechanical ventilation time must more than 24 hours
light or moderate sedation must needed

Exclusion

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 Design