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NCT Number: NCT07805876

The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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

Treatment and study plan

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.

Primary outcomes

  1. The incidence of postoperative delirium

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuming Peng, MD,Ph.D

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 8, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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