The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists physical status I to III

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;

. Compression or deformation of the ventricular system, particularly symmetric or asymmetric narrowing of the lateral ventricles and the third ventricle;

. Shallowed or absent sulci, fissures, and cisterns, with the subarachnoid spaces compressed due to brain tissue swelling or mass effect

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ciprofo

    Drug

    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.

  • Propofol

    Drug

    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.

Treatment groups

434 Participants
are divided into 2 treatment groups
Group A: Ciprofol groupExperimental treatment 1 intervention
Group B: Propofol groupOther 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of postoperative delirium

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.

Time frame
1 day before surgery to the 5th day after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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