Intracranial Tumors
Conditions
Brief summary
Postoperative delirium and postoperative ischemic stroke are common neurological complications in clinical practice. The incidence of these complications is further increased in patients undergoing neurosurgical procedures. Intraoperative hypotension and burst suppression are high-risk factors for postoperative delirium and ischemic stroke. Ciprofol, as a new intravenous general anesthetic, can significantly reduce the occurrence of hypotension and decrease burst suppression compared with propofol. However, no study has demonstrated that the application of ciprofol in neurosurgical patients can improve patient prognosis. Therefore, the purpose of this study is to explore the impact of using ciprofol or propofol in anesthesia induction and maintenance on postoperative neurological complications in patients with high intracranial pressure.
Interventions
DRUGCiprofo
During the induction of anaesthesia, a single bolus injection of 0.4 mg/kg ciprofol will be administered for rapid-sequence induction. During anaesthesia maintenance, ciprofol will be continuously infused at a dose of 0.4 - 2.4 mg/kg/h.
DRUGPropofol
During the induction of anaesthesia, a single bolus injection of 2 mg/kg propofol will be administered for rapid-sequence induction. During anaesthesia maintenance, propofol will be continuously infused at a dose of 2 - 5 mg/kg/h.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical status I to III * Patients scheduled for elective surgery for supratentorial intracranial tumors, with imaging findings meeting the following criteria: 1. Displacement of midline structures (e.g., septum pellucidum, pineal gland, falx cerebri) by ≥5 mm due to the tumor's mass effect or peritumoral edema; 2. . Compression or deformation of the ventricular system, particularly symmetric or asymmetric narrowing of the lateral ventricles and the third ventricle; 3. . Shallowed or absent sulci, fissures, and cisterns, with the subarachnoid spaces compressed due to brain tissue swelling or mass effect * Obtain written informed consent
Exclusion criteria
* History of transient ischemic attack or cerebral infarction within the past one year * Patients with a history of psychiatric or neurological disorders (such as depression, schizophrenia, epilepsy, Parkinson's disease, or severe myasthenia gravis) or those taking antipsychotic medications, antidepressants, glucocorticoids, as well as patients with alcohol abuse or illicit drug abuse * Personal history of intellectual disability or a preoperative Mini-Mental State Examination score indicating impaired cognitive function (defined as follows based on the subject's educational level: illiterate \< 17 points, elementary school education \< 20 points, middle school education or higher \< 24 points), language disorders, or inability to cooperate with the researcher during psychiatric assessment * Uncontrolled hypertension, diabetes, or a history of hematological disorders * Preoperative severe hepatic or renal insufficiency * Contraindications to the use of cyclopropane and propofol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative delirium | 1 day before surgery to the 5th day after surgery | Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable. |
Countries
China
Contacts
CONTACTYuming Peng, MD,Ph.D
PRINCIPAL_INVESTIGATORYuming Peng, MD,Ph.D
Beijing Tiantan Hospital
Outcome results
None listed