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

NCT ID: NCT06731088

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Midazolam

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: 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 benzenesulfonate

Group Type: ACTIVE_COMPARATOR

Remazolam besylate

Intervention Type: 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.

Interventions

Midazolam

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

Intervention Type: DRUG

Remazolam besylate

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Mechanical ventilation patients with sepsis who are expected to stay in ICU for ≥48h;

2. The condition was allowed to remain in shallow sedation (RASS-2 ~0);

3. Obtain informed consent from patients or family members

Exclusion Criteria

1. pregnancy or breastfeeding;

2. General anesthesia surgery within 48 hours;

3. Severe, pre-existing parenchymatous liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis or acute liver failure;

4. Patients with acute and chronic renal insufficiency requiring dialysis treatment;

5. 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;

6. Patients with a history of alcohol or drug abuse;

7. 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);

8. Failure to obtain informed consent or authorization;

9. Participate in other exploratory clinical trials within 6 months prior to screening;

10. Known or suspected allergy to the study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Ningbo University

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Countries

China

Other Identifiers

FAHNBU20241244

Identifier Type: -

Identifier Source: org_study_id