Critically ill patients
Conditions
Interventions
experimental group (remazolam mesylate combined with butorphanoltartrate):None
Sponsors
The First Affiliated Hospital, Jinan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged =18 years, gender not restricted; 2.Patients in the ICU undergoing tracheal intubation and mechanical ventilation who are expected to require sedation and analgesia for 24 to 72 hours (with a target sedation level of RASS score -3 to 0); 18kg/m2<BMI<30kg/m2; 3.Both the prospectively enrolled patients and their families are aware of the purpose of this study and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Subjects who have an allergic reaction to the drugs used in this study. 2.Subjects in the ICU requiring deep sedation. 3.Subjects expected to require neuromuscular blockers during sedation (excluding tracheal intubation). 4.Subjects whose conditions, such as blindness or deafness, affect the RASS assessment. 5.Subjects with psychiatric disorders (e.g., schizophrenia, depression) and cognitive impairments. 6.Subjects with organ failure before randomization (SOFA score > 9). 7.Subjects undergoing dialysis treatment during the screening period or expected to need dialysis during the study. 8.Subjects with a history of epilepsy or status epilepticus during the screening period. 9.Subjects with a history of substance abuse, including psychiatric or anesthetic drugs. 10.Subjects post-neurosurgery (e.g., craniotomy or spinal surgery), with neurological dysfunction, and/or in a coma. 11.Subjects dependent on naloxone, with significant respiratory depression, or known/suspected gastrointestinal obstruction. 12.Subjects deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation and analgesia compliance rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dosage of sedative and analgesic drugs;Proportion of subjects with analgesic remediation and number of remediations;Proportion of subjects sedated for remediation and number of remediations performed;Vasopressors;Delirium;Duration of mechanical ventilation;Evaluate the time from when offline is available to when offline is complete;ICU Length of Stay (ICU LOS);Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactHaiyan Yin
The First Affiliated Hospital, Jinan University
Outcome results
None listed