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

NCT07799623 | Not Yet Recruiting

• 1 other identifier: 1205-01
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Neoplasms; Delirium - Postoperative

Keywords

Ciprofol; Propofol; Sevoflurane; Postoperative Delirium; Brain Neoplasms; General Anesthesia; Aged; Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Delirium Within 7 Days After Surgery as Assessed by the Confusion Assessment Method (CAM)

  Delirium is diagnosed using the Confusion Assessment Method (CAM). A positive CAM assessment requires the simultaneous presence of Feature 1 (acute onset and fluctuating course) and Feature 2 (inattention), plus either Feature 3 (disorganized thinking) or Feature 4 (altered level of consciousness). The outcome is reported as the proportion of participants with at least one positive CAM assessment during the 7-day postoperative period.

  Postoperative 2 hours, 6-12 hours, and twice daily (08:00-10:00 and 18:00-20:00) from postoperative Day 1 through Day 7

Secondary Outcomes (18)

• Duration of Postoperative Delirium in Days During the First 7 Days After Surgery

  Postoperative Day 1 through Day 7

• Mean Daily CAM-Severity (CAM-S) Score During the First 7 Days After Surgery

  Postoperative Day 1 through Day 7 (twice daily assessments)

• Change in Cognitive Function From Baseline as Assessed by T-MoCA at 7 Days After Surgery

  Baseline (1 day before surgery) and postoperative Day 7

• Change in Cognitive Function From Baseline as Assessed by T-MoCA at 30 Days After Surgery

  Baseline (1 day before surgery) and postoperative Day 30

• Change in Cognitive Function From Baseline as Assessed by T-MoCA at 90 Days After Surgery

  Baseline (1 day before surgery) and postoperative Day 90

Study Arms (3)

Ciprofol Group

EXPERIMENTAL

Participants will receive ciprofol for general anesthesia induction (0.3-0.4 mg/kg intravenous injection) and maintenance (0.4-2.4 mg/kg/h continuous intravenous infusion) during elective brain tumor resection.

Drug: Ciprofol

Propofol Group

ACTIVE COMPARATOR

Participants will receive propofol for general anesthesia induction (1.5-2.0 mg/kg intravenous injection) and maintenance (4-12 mg/kg/h continuous intravenous infusion) during elective brain tumor resection.

Drug: Propofol

Sevoflurane Group

ACTIVE COMPARATOR

Participants will receive sevoflurane for general anesthesia induction (7-8% inhaled) and maintenance (1.0-3.0% inhaled) during elective brain tumor resection.

Drug: Sevoflurane

Interventions

Ciprofol DRUG

Ciprofol injectable emulsion (20 mL: 50 mg) administered intravenously for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 0.3-0.4 mg/kg by slow intravenous injection over ≥30 seconds. Maintenance: continuous intravenous infusion at 0.4-2.4 mg/kg/h via infusion pump, beginning after induction and continuing until the end of surgery. Dose adjustments are made based on patient response and hemodynamic monitoring. Total duration depends on operative time.

Ciprofol Group

Propofol DRUG

Propofol injectable emulsion administered intravenously for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 1.5-2.0 mg/kg by slow intravenous injection over ≥30 seconds. Maintenance: continuous intravenous infusion at 4-12 mg/kg/h via infusion pump, beginning after induction and continuing until the end of surgery. Dose adjustments are made based on patient response and hemodynamic monitoring. Total duration depends on operative time.

Propofol Group

Sevoflurane DRUG

Sevoflurane inhalation solution (volatile liquid) administered via inhalation through a calibrated vaporizer for general anesthesia induction and maintenance during elective brain tumor resection. Induction: 7-8% inhaled concentration with oxygen flow 2-4 L/min until loss of consciousness. Maintenance: inhaled concentration adjusted to 1.0-3.0% and titrated to effect; concentration is gradually reduced beginning 30 minutes before the anticipated end of surgery and discontinued at the end of the procedure. Total duration depends on operative time.

Sevoflurane Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Preoperative delirium, dementia, diagnosed severe psychiatric disorder, or existing central nervous system disease.
• History of alcohol addiction or drug abuse; suspected or confirmed long-term use of narcotic analgesics or sedatives.
• Severe visual, auditory, or speech impairment that precludes communication and cognitive testing.
• 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).
• Known difficult airway, malignant hyperthermia susceptibility, or other contraindication to general anesthesia.
• Hypersensitivity or known allergy to ciprofol, propofol, sevoflurane, or other study-related agents.
• Severe uncontrolled infection or endocrine disorder.
• Concurrent participation in another clinical trial.
• Judged unsuitable for enrollment by the attending surgeon, anesthesiologist, or principal investigator for any other reason.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Brain Neoplasms; Emergence Delirium

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol; Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Central Study Contacts

Tingting Wang, Ph.D.

CONTACT

+86-13667265360; Wangtt201307@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 2, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): July 3, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)