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The effects of different inspired oxygen concentrations during surgery on postoperative oxidative stress and postoperative cognitive dysfunction in frail elderly patients

The effects of different inspired oxygen concentrations during surgery on postoperative oxidative stress and postoperative cognitive dysfunction in frail elderly patients

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095103
Enrollment
Unknown
Registered
2025-01-02
Start date
2025-01-02
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative cognitive dysfunction

Interventions

Hyperoxia group:After the confirmation of endotracheal intubation, the subjects will be ventilated with FiO? = 1.0 and maintain ventilation with FiO? = 1.0 throughout all intraoperative mechanical ven
Physiological oxygenation group.:Immediately after intubation by the anesthesiologist, the FiO? will be reduced to 0.21. Subsequently, the anesthesiologist will increase or decrease the FiO? during pu

Sponsors

Huai'an Hospital Affiliated to Yangzhou University (The Fifth People's Hospital of Huai'an)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged 65 years or older; (2) Undergoing major non-cardiac surgeries under general anesthesia (with an expected postoperative hospital stay of more than 2 days); (3) Meeting the frailty criteria.

Exclusion criteria

Exclusion criteria: (1) Patients with disabling neuropsychiatric or neurological disorders (such as severe dementia, Alzheimer's disease, schizophrenia, severe depression); (2) Patients with delirium; (3) Patients who are unable to complete preoperative mental tests; (4) Use of home supplemental oxygen; (5) Preoperative supplemental oxygen to maintain an arterial oxygen saturation of 92%; (6) Right-to-left intracardiac shunts including atrial septal defect and ventricular septal defect combined with cor pulmonale; (7) Carotid artery stenosis defined as 50% stenosis of any carotid artery; (8) Currently using hemodialysis or peritoneal dialysis; (9) Patients who need to be transferred to the ICU after surgery.

Design outcomes

Primary

MeasureTime frame
Plasma F2 - isoprostane and isofuran concentrations;Serum S100ß;

Secondary

MeasureTime frame
Cerebral oxygen saturation;Mini - Mental State Examination;Confusion Assessment Method for the Intensive Care Unit;The Incidence of Postoperative Cognitive Dysfunction;The Incidence of Postoperative Delirium;Postoperative complications;

Countries

China

Contacts

Public ContactJingjing Mao

Huai'an Hospital Affiliated to Yangzhou University (The Fifth People's Hospital of Huai'an)

35035587@qq.com+86 186 6295 8120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026