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

RECRUITINGPhase 4Sponsored by Beijing Shijitan Hospital, Capital Medical University
Actively Recruiting
PhasePhase 4
SponsorBeijing Shijitan Hospital, Capital Medical University
Started2025-01-20
Est. completion2026-04-20
Eligibility
Age18 Years – 64 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06575530

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

Age: 18 Years – 64 YearsHealthy volunteers accepted
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.

Conditions7

Adverse Drug EventCritical IllnessEffect of DrugHeart DiseaseMechanical Ventilation ComplicationSedationSurgery

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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