RecruitingNot ApplicableNCT06788743

Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial


Sponsor

Xijing Hospital

Enrollment

450 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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. 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

Min Age: 60 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

DRUGTIVA ( anesthesia with propofol and remifentanil)

Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery

DRUGVA(anesthesia with sevoflurane and remifentanil)

Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.


Locations(1)

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China

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NCT06788743


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