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

First Affiliated Hospital of Ningbo University

Status and phase: Invitation-only; Phase 4

Conditions: Sepsis

Treatments: Drug: Remazolam besylate; Drug: Midazolam

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06731088

FAHNBU20241244

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Midazolam

Active Comparator group

Treatment:

Drug: Midazolam

Remazolam benzenesulfonate

Active Comparator group

Treatment:

Drug: Remazolam besylate