The Effect of Ciprofol Versus Propofol Anesthesia on Postoperative Neurological Complications

NCT07805876 | Not Yet Recruiting

• 1 other identifier: 20260831
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Tumors

Outcome Measures

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.

  1 day before surgery to the 5th day after surgery

Study Arms (2)

Ciprofol group

EXPERIMENTAL

Participants will undergo anaesthesia induction with ciprofol, followed by total intravenous anaesthesia with ciprofol for maintenance.

Drug: Ciprofo

Propofol group

OTHER

Participants will undergo anaesthesia induction with propofol, followed by total intravenous anaesthesia with propofol for maintenance.

Drug: Propofol

Interventions

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.

Ciprofol group

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.

Propofol group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Propofol

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yuming Peng, MD,Ph.D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Peng, MD,Ph.D

CONTACT

8610-59976658; florapym766@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 8, 2026
• Study Start: September 7, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: September 9, 2026

Record last verified: 2026-09

Locations

CN (1)