Acquired head injury
Conditions
Interventions
Control group:Intravenous infusion of propofol
Experimental group:Intravenous infusion of remimazolam
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with acquired head injury who are intended to be treated with flexible bronchoscopy under sedation; 2. Age 18~75 years old; 3. Patients who have passed the acute phase after medical treatment, have stable vital signs, tracheotomy, and are in the chronic phase; 4. Glasgow Rating>8 points, ASA Grade II.~III; 5. Voluntarily or family members agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergies to benzodiazepines, propofol, flumazenil, opioids, or certain drugs; 2. Patients who have been using benzodiazepines or opioids for a long time, or have a history of drug and alcohol abuse; 3. Patients with abnormal intracranial pressure such as chronic hydrocephalus, skull defect, and intracranial infection; 4. Severe sinus bradycardia (HR=200mmHg and/or diastolic blood pressure >=120mmHg, MAP <70mmHg; 5. Severe cardiac, hepatic and/or renal dysfunction; 6. Patients who have participated in other clinical trials within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of hypotension during sedation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sedation success rate;The rate of respiratory depression requiring mechanical ventilation support.;Bronchoscopist satisfaction;The total dose of vasopressor required to restore blood pressure;Time to recovery from anesthesia;The time to reach the sedation endpoint.;Postoperative nausea and vomiting (PONV); | — |
Countries
China
Contacts
Public ContactJinjun Bian
Shanghai Changhai Hospital
Outcome results
None listed