Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With Sepsis

First Affiliated Hospital of Ningbo University1 site in 1 country100 target enrollmentJanuary 1, 2025

ConditionsSepsis

InterventionsMidazolam Remazolam besylate

DrugsMidazolam Remazolam besylate

Overview

Phase: Phase 4
Intervention: Midazolam
Conditions: Sepsis
Sponsor: First Affiliated Hospital of Ningbo University
Enrollment: 100
Locations: 1
Primary Endpoint: The number of days without delirium or coma during the 14-day intervention period.
Status: Enrolling By Invitation
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, midazolam was used as a control to investigate the effect of remazolam besylate combined with remifentanil on analgesia and sedation in patients with mechanical ventilation of sepsis on the prognosis of patients, and to provide evidence for the safe application of remazolam besylate in patients with sepsis.

Registry

clinicaltrials.gov

Start Date

January 1, 2025

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

First Affiliated Hospital of Ningbo University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Mechanical ventilation patients with sepsis who are expected to stay in ICU for ≥48h;
•The condition was allowed to remain in shallow sedation (RASS-2 \~0);
•Obtain informed consent from patients or family members

Exclusion Criteria

•pregnancy or breastfeeding;
•General anesthesia surgery within 48 hours;
•Severe, pre-existing parenchymatous liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis or acute liver failure;
•Patients with acute and chronic renal insufficiency requiring dialysis treatment;
•Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc. 6 Medical Ethics Committee of the First Affiliated Hospital of Ningbo University;
•Patients with a history of alcohol or drug abuse;
•Any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction);
•Failure to obtain informed consent or authorization;
•Participate in other exploratory clinical trials within 6 months prior to screening;
•Known or suspected allergy to the study drug.