Elderly Patients With Traumatic Head Injury
Conditions
Interventions
Cyclopofol group:Cyclopofol 0.5mg/kg/h
Propofol group:Propofol 1.5mg/kg/h
Sponsors
North China University of Science and Technology Affiliated Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with severe head injury by CT or MRI examination and requiring invasive mechanical ventilation; 2. not receiving treatment prior to admission; 3. No surgical treatment; 4. Glasgow Coma Scale score 72 hours; 7. Age >= 65 years old; 8. The patient's legal representative voluntarily signed the informed consent form and strictly abided by the clinical study protocol to complete the study.
Exclusion criteria
Exclusion criteria: 1. Those who have contraindications to deep sedation/general anesthesia or who have had a history of sedation/anesthesia accidents in the past; 2. Those who are known to be allergic to eggs, soy products, opioids and their antidotes, propofol, etc.; Propofol, opioids and their antidote contraindications; 3. Patients with other organ failure (such as liver, kidney, etc.); (1) History of cardiovascular disease: uncontrolled hypertension [systolic blood pressure (SBP) >= 170 mmHg and/or diastolic blood pressure (DBP) >=105 mmHg without antihypertensive medication, or SBP >160 mmHg and/or DBP>100 mmHg] after antihypertensive drug therapy, severe cardiac arrhythmia, heart failure, Adams-stokes syndrome, unstable angina, myocardial infarction within the past 6 months prior to screening, history of tachycardia/bradycardia requiring medication, Third-degree atrioventricular block or QTcF interval >= 450 ms (corrected by Fridericia's formula); (2) History of respiratory system: history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months prior to screening, or severe pneumonia; (3) History of neuropsychiatric system: combined with schizophrenia, mania, long-term use of psychotropic drugs, etc.; Patients with acute cerebrovascular accident (such as acute cerebral infarction, acute cerebral hemorrhage, craniocerebral mass, etc.); 4. ICU stay of less than 72 hours; 5. Subjects who, in the opinion of the investigator, have any other factors that are not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean arterial pressure;APACHEII score;Glasgow score;Time of vasoactive drug application;Oxygenation index;blood lactate;arterial partial pressure of oxygen (PaO2);central venous oxygen saturation (ScVO2);intracranial pressure (ICP);cerebral oxygen uptake rate (CERO2);Cerebral oxygen saturation;internal jugular arteriovenous oxygen content (DajvO2);Internal jugular vein oxygen saturation;Neuron-specific enolases;Duration of mechanical ventilation;Serum S-100ß protein;Systolic blood pressure;Diastolic blood pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| sex;year;blood lipids;neutrophil elastase 2;Survival status within 28 days;heart rate;Respiratory rate; | — |
Countries
China
Contacts
Public ContactCheng Aibin
North China University of Science and Technology Affiliated Hospital
Outcome results
None listed