The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications in Patients With Increased Intracranial Pressure Caused by Intracranial Tumors: a Randomized Controlled Trial
| Registry | NCT07805876 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 434 (Estimated) |
| Sponsor | Beijing Tiantan Hospital (Other) |
| Conditions | Intracranial Tumors |
| Interventions | Ciprofo, Propofol (Drug) |
| Dates | start 2026-09-07 (estimated), primary completion 2028-09-30 (estimated), completion 2029-03-31 (estimated), first posted 2026-09-08, last updated 2026-09-09 |
| Locations | 1 site in China |
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All trials for Intracranial Tumors All trials of Ciprofo All trials of Propofol
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Ciprofol group | Experimental | Drug: Ciprofo | Participants will undergo anaesthesia induction with ciprofol, followed by total intravenous anaesthesia with ciprofol for maintenance. |
| Propofol group | Other | Drug: Propofol | Participants will undergo anaesthesia induction with propofol, followed by total intravenous anaesthesia with propofol for maintenance. |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Tian Tan Hospital, Capital Medical University | Beijing, Beijing Municipality | China |