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

NCT06788743 | Recruiting

• 1 other identifier: NCT06788743
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Delirium (POD); Diabetes

Outcome Measures

Primary Outcomes (1)

• the incidence of delirium

  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 Outcomes (4)

• The severity of POD

  within the first 7 postoperative days

• The duration of POD

  within the first 7 postoperative days

• The length of hospital stay

  the first 7 postoperative days

• Blood glucose levels

  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 Outcomes (3)

• Serum insulin levels

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

• Serum inflammatory factor (IL-6) levels

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

• Serum neurodegenerative factor (S-100β protein) levels

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

Study Arms (2)

TIVA

EXPERIMENTAL

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)

VA

EXPERIMENTAL

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）

Interventions

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

TIVA

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.

VA

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Diabetes Mellitus

Interventions

Anesthesia; Propofol; Remifentanil; Sevoflurane

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Central Study Contacts

Huang Nie

CONTACT

＋86 13201630298; niehuang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: June 1, 2025
• Primary Completion: April 24, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 16, 2026

Record last verified: 2025-06

Locations

CN (1)