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Enrolling by Invitation

NCT Number: NCT06731088

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315040, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

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

    Time frame: From enrollment to the end of treatment at 14 days

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Ningbo University

Network

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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