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Impact of Volatile Versus Total Intravenous Anesthesia on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial

Impact of Volatile Versus Total Intravenous Anesthesia on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial

Recruiting
60 years and older
All
Phase N/A

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Overview

The present study is a multicenter, randomized controlled clinical trial, which plans to enroll 450 diabetic patients aged more than 60 years. The participants will be randomly assigned in a 1:1 ratio and will receive either propofol or sevoflurane for intraoperative anesthesia maintenance to evaluate the impact of these two anesthetic drugs on postoperative delirium. The aim of our study is to explore whether the use of propofol for anesthesia maintenance in elderly diabetic patients undergoing elective non-cardiac major surgery can reduce the incidence of postoperative delirium. Exploratory analysis was conducted to observe the differences in perioperative levels of blood glucose, serum insulin, inflammatory factors (IL-6, IL-1β, TNF-α), neuroinjury markers (S-100β protein, neuron-specific enolase) between the two groups. This study will provide new perspectives for improving perioperative management in elderly diabetic patients and optimizing anesthesia management strategies to reduce the risk of postoperative delirium.

Eligibility

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:

  • 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 who are expected to require hepatic portal blockage during surgery
  • Patients who are expected to be transferred to ICU after surgery
  • Patients with a known allergy to the drugs used in this study or those suspected of having propofol infusion syndrome

Study details
    Postoperative Delirium (POD)
    Diabetes

NCT06788743

Xijing Hospital

1 August 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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