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

April 13, 2026 updated by: Xijing Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanxi
      • Xi’an, Shanxi, China, 710032
        • Recruiting
        • The First Affiliated Hospital of Air Force Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVA
Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery
Drug: TIVA ( anesthesia with propofol and remifentanil)
Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery
Experimental: VA
Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.
Drug: VA（anesthesia with sevoflurane and remifentanil）
Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within the first 7 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
within the first 7 postoperative days
The duration of POD
Time Frame: within the first 7 postoperative days
The total number of days with positive results.
within the first 7 postoperative days
The length of hospital stay
Time Frame: the first 7 postoperative days
the first 7 postoperative days
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).
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)

Other Outcome Measures

Outcome Measure
Time Frame
Serum inflammatory factor (IL-6) levels
Time Frame: post-operative days 1 and 2 (T5, T6)
post-operative days 1 and 2 (T5, T6)
Serum neurodegenerative factor (S-100β protein) levels
Time Frame: post-operative days 1 and 2 (T5, T6)
post-operative days 1 and 2 (T5, T6)
Serum insulin levels
Time Frame: at 1 h and 2 h after incision(T1, T2)
at 1 h and 2 h after incision(T1, T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

April 24, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT06788743

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on TIVA ( anesthesia with propofol and remifentanil)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe