Ciprofol, Propofol and Sevoflurane for Postoperative Delirium in Elderly Brain Tumor Patients

Ciprofol, Propofol and Sevoflurane for Postoperative Delirium in Elderly Brain Tumor Patients

This study will compare three anesthesia medicines used to put people into a deep sleep during surgery: ciprofol, propofol, and sevoflurane. All three are commonly used for general anesthesia, but they work in different ways. Ciprofol and propofol are given through a vein. Sevoflurane is breathed in as a gas. After brain tumor surgery, some older adults may develop sudden confusion and memory problems called delirium. Researchers want to learn which of these three medicines is best at preventing delirium and protecting brain function in older adults undergoing brain tumor surgery.

About 381 participants aged 65 to 90 will take part. Participants will be randomly assigned to one of three groups. One group will receive ciprofol. Another group will receive propofol. The third group will receive sevoflurane. All participants will receive standard care during and after brain tumor removal.

The main goal is to compare how many participants develop delirium within 7 days after surgery. Researchers will also look at how long delirium lasts, how severe it is, thinking and memory skills at 7, 30, 90, and 180 days after surgery, quality of recovery, blood pressure and heart rate during surgery, and treatment safety.

Blood tests will be used to measure markers of body stress, inflammation, and nerve cell injury before surgery, 3 hours after surgery, and 1 day after surgery. Researchers will also test thinking and memory with simple questions twice a day for 7 days after surgery. Later follow-up will be done by phone at 30, 90, and 180 days after surgery.

This study is designed to explore which anesthesia medicine is safest and best at protecting the brain after surgery in older adults with brain tumors. The results may help doctors choose the best anesthesia for this group of patients in the future.

Inclusion Criteria:

1. Aged 65 to 90 years, either sex.
2. Scheduled to undergo elective brain tumor resection under general anesthesia.
3. American Society of Anesthesiologists (ASA) physical status I-III.
4. Expected operative time ≥ 2 hours and anticipated postoperative hospital stay > 48 hours.
5. Able to communicate in Chinese and complete cognitive assessments.
6. Preoperative cognitive function intact: Telephone Montreal Cognitive Assessment (T-MoCA) score ≥ 18 and Confusion Assessment Method (CAM) negative.
7. No use of analgesic or sedative medications on the day before surgery.
8. Able to provide informed consent and willing to comply with postoperative follow-up through 180 days.

Exclusion Criteria:

1. Preoperative use of medications that may affect postoperative cognition (e.g., long-term benzodiazepines, antidepressants, antipsychotics, or chronic sedative-hypnotic use that cannot be paused).
2. Preoperative delirium, dementia, diagnosed severe psychiatric disorder, or existing central nervous system disease.
3. History of alcohol addiction or drug abuse; suspected or confirmed long-term use of narcotic analgesics or sedatives.
4. Severe visual, auditory, or speech impairment that precludes communication and cognitive testing.
5. Severe cardiopulmonary disease: forced expiratory volume in 1 second (FEV1) or vital capacity < 50% of predicted; New York Heart Association (NYHA) functional class III-IV; severe hepatic or renal insufficiency (creatinine > 176 μmol/L, blood urea nitrogen > 7.1 mmol/L, albumin < 30 g/L, Child-Pugh class C, or preoperative dialysis).
6. Known difficult airway, malignant hyperthermia susceptibility, or other contraindication to general anesthesia.
7. Hypersensitivity or known allergy to ciprofol, propofol, sevoflurane, or other study-related agents.
8. Severe uncontrolled infection or endocrine disorder.
9. Concurrent participation in another clinical trial.
10. Judged unsuitable for enrollment by the attending surgeon, anesthesiologist, or principal investigator for any other reason.