The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracranial Tumors
• Intervention / Treatment: Drug: Ciprofo; Drug: Propofol

• Study Type: Interventional
• Enrollment (Estimated): 434
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuming Peng, MD,Ph.D; Phone Number: 8610-59976658; Email: florapym766@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tian Tan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ciprofol group; Participants will undergo anesthesia induction by ciprofol, and receive total intravenous anesthesia by ciprofol to maintain.	Drug: Ciprofo; During the induction of anesthesia, a single bolus injection of 0.4mg/kg of ciprofol was administered for rapid sequence induction. During the period of anesthesia maintenance, it was continuously infused at a dose of 0.4 - 2.4 mg/kg/h.
Other: Propofol group; Participants will undergo anesthesia induction by propofol, and receive total intravenous anesthesia by propofol to maintain.	Drug: Propofol; During the induction of anesthesia, a single bolus injection of 2 mg/kg of propofol was administered for rapid sequence induction. During the period of anesthesia maintenance, it was continuously infused at a dose of 2-5 mg/kg/h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day before surgery to the 5th day after surgery

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Yuming Peng, MD,Ph.D, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 7, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol
• Other Study ID Numbers: 20260831

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No