Sedation Efficacy and Safety of Remifentanil in Ventilated Surgical Critically Ill Patients
NCT Number: NCT06575530
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Effect of Drug|Adverse Drug Event|Mechanical Ventilation Complication|Critical Illness|Surgery|Sedation
Interventions: DRUG: sedation drug
Sponsor: Beijing Shijitan Hospital, Capital Medical University
Sex: ALL
Age: ADULT
Enrollment: 306
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-08-30
Completion Date: 2025-10-30

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.

Primary Outcome Measures: MV time, Mechanical ventilated time during the ICU stay after surgery, Through the mechanical ventilation in the ICU after surgery, an average of 3 days
Secondary Outcome Measures: Dosage of remedial sedatives, Dosage of remedial sedatives during mechanical ventilation in the ICU, Through the useage of sedative drugs in the ICU, an average of 3 days|Frequency of remedial sedatives, Frequency of remedial sedatives during mechanical ventilation in the ICU, Through the useage of sedative drugs in the ICU, an average of 3 days|Delirium incidence, Delirium incidence during the patients' ICU stay, assessed using ConfusionAssessmentMethodfortheIntensive CareUnit(CAM-ICU, 4 items), delirium is diagnosed when 3 items are met, Through the ICU stay, an average of 3 days|Proportional of predicted sedation time, Proportional of predicted sedation time during sedation time in the ICU, sedation depth is assessed using Richmond Agitation Sedation Scale(RASS, -5 to +4), predicted sedation must has a RASS score -3 to 0., Through the useage of sedative drugs in the ICU, an average of 3 days|Extubation time after termination of sedation, Extubation time(hour) after termination of sedation, From ICU admission to extubation, an average of 3 days|Re-mechanical ventilation incidence after weaning and extubation, Re-mechanical ventilation incidence after weaning and extubation, Through the ICU stay, an average of 3 days|Proportion of different oxygen therapies after extubation, Proportion of different oxygen therapies after extubation, Through the ICU stay, an average of 3 days|Pain assessment score the first 3 days after surgery, Pain assessment score the first 3 days after surgery, assessed using Critical-Care Pain Observation Tool(CPOT,0-8), the higher the score, the more painful the patient feels, The first 3 days of ICU stay, an average of 3 days|Sleep quality score the day transfer out of ICU, Sleep quality score the day transfer out of ICU, assessed using St.Mary'sHospitalSleepQuestionnaire(SMHSQ, 11 to 55), the lower the score, the higher the degree of sleep disorders, The day transfer out of ICU, an average of 1day|Cognitive assessment score 60 days after surgery, Cognitive assessment score 60 days after surgery, assessed using Telephone Interview for Cognitive Status-Modified(TICS-m,0-50), the higher the score, the better the cognitive function, Day 60 after surgery, an average of 1 day|Sleep quality score 60 days after surgery, Sleep quality score 60 days after surgery, assessed using Pittsburgh sleep quality index(PSQI,0-21), the higher the score, the worse the sleep quality, Day 60 after surgery, an average of 1 day|ICU LOS, ICU length of stay, The day the patient transfer out of ICU, an average of 1 day|Hospital LOS after surgery, Hospital length of stay after surgery, The day the patient discharge, an average of 1 day|All cause mortality 60 days after surgery, All cause mortality 60 days after surgery, Day 60 after surgery, an average of 1 day|Non-neurological complications 60 days after surgery, Non-neurological complications 60 days after surgery, Day 60 after surgery, an average of 1 day