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

NCT06731088 | Enrolling By Invitation Phase 4

• 1 other identifier: FAHNBU20241244
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• The number of days without delirium or coma during the 14-day intervention period.

  From enrollment to the end of treatment at 14 days

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

Drug: Midazolam

Remazolam benzenesulfonate

ACTIVE COMPARATOR

Drug: Remazolam besylate

Interventions

Midazolam DRUG

Midazolam, a benzodiazepine sedative commonly used in ICU, acts on GABA receptors in the central nervous system to produce dose-related hypnosis, anti-pyroanxiety and anterograde amnesia, and has corresponding competitive antagonists \[8\]. It has rapid onset and short duration, but its deficiency lies in that the metabolites are still active. Thus easy accumulation, prolong the recovery time of patients

Midazolam

Remazolam besylate DRUG

Remazolam besylate is a new type of benzodiazepine sedative drug metabolized by tissue esterase. It is not metabolized by liver and kidney, and is metabolized by tissue esterase rapidly in vivo to produce inactive metabolites.

Remazolam benzenesulfonate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead

Study Sites (1)

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315040, China

Location

MeSH Terms

Conditions

Sepsis

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

CN (1)