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NCT Number: NCT06788743

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

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.

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Key information

Conditions

Postoperative Delirium (POD) Confusion Delirium Diabetes Diabetes Mellitus Emergence Delirium Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, 710032, China

Location status: Recruiting

Location contact

Jiangru Kang

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIVA ( anesthesia with propofol and remifentanil)

Drug

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

VA（anesthesia with sevoflurane and remifentanil）

Drug

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

Primary outcomes

  1. the incidence of delirium

    Time frame: within the first 7 postoperative days

    Postoperative delirium will be assessed daily at 8:00 AM and 6:00 PM from postoperative days 1 to 7, or until discharge, using the 3D-CAM scale.

Secondary outcomes

  1. The severity of POD

    Time frame: within the first 7 postoperative days

    The severity of postoperative delirium will be evaluated with the 4-item CAM-S scale (total score: 7 points, where 0 points indicates no delirium; 1 point indicates mild delirium; 2 points indicates moderate delirium; 3-7 points indicate severe delirium).

  2. The duration of POD

    Time frame: within the first 7 postoperative days

    The total number of days with positive results.

  3. The length of hospital stay

    Time frame: the first 7 postoperative days

  4. Blood glucose levels

    Time frame: before anesthesia induction (T0), 1 h and 2 h after incision (T1, T2), at skin closure (T3), before PACU discharge (T4), and on post-operative days 1 and 2 (T5, T6)

    During the surgery, bedside capillary blood glucose levels will be measured using a portable blood glucose meter (capillary blood).

Other outcomes

  1. Serum insulin levels

    Time frame: at 1 h and 2 h after incision(T1, T2)

  2. Serum inflammatory factor (IL-6) levels

    Time frame: post-operative days 1 and 2 (T5, T6)

  3. Serum neurodegenerative factor (S-100β protein) levels

    Time frame: post-operative days 1 and 2 (T5, T6)

Study contacts

Contact information is provided by the study sponsor or research team.

Huang Nie

CONTACT

[email protected]

＋86 13201630298

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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