Sepsis
Conditions
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.
Interventions
DRUGMidazolam
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 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.
Sponsors
First Affiliated Hospital of Ningbo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of days without delirium or coma during the 14-day intervention period. | From enrollment to the end of treatment at 14 days |
Countries
China
Outcome results
None listed