Clinical trial NCT06575530: Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients
Official title: Efficacy and Safety of Remazolam Besylate in Patients Requiring Mechanical Ventilation Admitted to ICU After Non-cardiac Surgery: Protocol for a Randomized, Controlled No-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Effect of Drug
Adverse Drug Event
Mechanical Ventilation Complication
Critical Illness
Surgery
Sedation
Lead sponsor: Beijing Shijitan Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: ventilation free days
timeFrame: Through the initiation of enrollment to 28 days, an average of 1 day
Secondary outcomes:
measure: Dosage of remedial sedatives
timeFrame: Through the useage of sedative drugs in the ICU, an average of 3 days
measure: Frequency of remedial sedatives
timeFrame: Through the useage of sedative drugs in the ICU, an average of 3 days
measure: Delirium incidence
timeFrame: Through the ICU stay, an average of 3 days
measure: Proportional of predicted sedation time
timeFrame: Through the useage of sedative drugs in the ICU, an average of 3 days
measure: Extubation time after termination of sedation
timeFrame: From ICU admission to extubation, an average of 3 days
measure: Re-mechanical ventilation incidence after weaning and extubation
timeFrame: Through the ICU stay, an average of 3 days
measure: Proportion of different oxygen therapies after extubation
timeFrame: Through the ICU stay, an average of 3 days
measure: Pain assessment score the first 3 days after surgery
timeFrame: The first 3 days of ICU stay, an average of 3 days
measure: Sleep quality score the day transfer out of ICU
timeFrame: The day transfer out of ICU, an average of 1day
measure: Cognitive assessment score 60 days after surgery
timeFrame: Day 60 after surgery, an average of 1 day
measure: Sleep quality score 60 days after surgery
timeFrame: Day 60 after surgery, an average of 1 day
measure: ICU LOS
timeFrame: The day the patient transfer out of ICU, an average of 1 day
measure: Hospital LOS after surgery
timeFrame: The day the patient discharge, an average of 1 day
measure: All cause mortality 60 days after surgery
timeFrame: Day 60 after surgery, an average of 1 day
measure: Non-neurological complications 60 days after surgery
timeFrame: Day 60 after surgery, an average of 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital.CMU
state: Beijing
Study officials:
affiliation: Beijing Shijitan Hospital, Capital Medical University
name: Jianxin Zhou, doctor
role: STUDY_CHAIR
References: