Propofol versus sevoflurane for anesthesia maintenance in older adults with diabetes having major non-cardiac surgery
Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial
This study will try whether using propofol instead of sevoflurane during surgery reduces postoperative delirium in people aged 60 and older with diabetes undergoing major non-cardiac operations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi’an, Shanxi) |
| Trial ID | NCT06788743 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized controlled trial plans to enroll 450 patients aged 60 years or older with diabetes who are scheduled for elective major non-cardiac surgery expected to last two hours or more. Participants will be randomized 1:1 to receive intraoperative maintenance with either total intravenous anesthesia (propofol plus remifentanil) or inhalational anesthesia (sevoflurane plus remifentanil). Postoperative delirium incidence will be monitored during the early postoperative period using standard clinical assessments, alongside routine perioperative safety monitoring. The goal is to determine whether propofol-based maintenance reduces delirium risk and to inform anesthesia management for elderly diabetic patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 60 or older with diabetes who can give informed consent and are scheduled for elective major non-cardiac surgery expected to last two hours or more.
Not a fit: Patients with significant cognitive impairment, severe hepatic dysfunction or dialysis-dependent renal failure, neurosurgical procedures, BMI ≥35 kg/m², long-term sedative or antipsychotic use, or known allergy/suspected propofol infusion syndrome are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could identify an anesthesia approach that lowers the risk of postoperative delirium in older patients with diabetes.
How similar studies have performed: Prior randomized trials and meta-analyses have suggested propofol-based total intravenous anesthesia may reduce postoperative delirium in some groups, but results are mixed and not conclusive specifically for elderly patients with diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥60 years * Elective surgery (with an expected duration of 2 hours or more) * ASA grade Ⅰ-Ⅲ * Voluntary participation and informed consent obtained * Diabetes mellitus Exclusion Criteria: * Pre-operative BMI≥35 kg/m² (Class II obesity or above) * Severe hepatic dysfunction (Child-Pugh class C) or pre-operative dialysis-dependent renal dysfunction * Known neurological or psychiatric diseases (Parkinson's disease, depression, schizophrenia), or cognitive impairment (dementia) * Severe visual or auditory impairments, language barriers, or patients who cannot cooperate * Long-term use of sedatives, antipsychotic drugs, or long-term alcohol abuse * Neurosurgical patients * Patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome
Where this trial is running
Xi’an, Shanxi
- The First Affiliated Hospital of Air Force Medical University — Xi’an, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Huang Nie
- Email: niehuang@163.com
- Phone: ＋86 13201630298
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.