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

Not Applicable

Recruiting

• Conditions: Postoperative Delirium (POD); Diabetes
• Interventions: Drug: TIVA ( anesthesia with propofol and remifentanil); Drug: VA（anesthesia with sevoflurane and remifentanil）

• Registration Number: NCT06788743
• Lead Sponsor: Xijing Hospital

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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-17
• Study First Posted: 2025-01-23
• Study Start: 2025-06-01
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-17
• Primary Completion: 2025-12-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVA	TIVA ( anesthesia with propofol and remifentanil)	Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery
VA	VA（anesthesia with sevoflurane and remifentanil）	Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.

Primary Outcome Measures

Name	Time	Method
the incidence of delirium	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 Outcome Measures

Name	Time	Method
The severity of POD	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).
The length of hospital stay	the first 7 postoperative days
Blood glucose levels	before anesthesia induction (T0), intubation (T1), skin incision (T2), 1 and 2 hours after the start of surgery (T3, T4), suturing (T5), extubation (T6), before discharge from PACU (T7), postoperative days 1 and 2 (T8, T9)	During the surgery, bedside capillary blood glucose levels will be measured using a portable blood glucose meter (capillary blood).
Insulin levels	Preoperative and postoperative 1-hour, 2-hour
IL-6, IL-1β, and TNF-α levels	Preoperative and postoperative days 1 and 2
S-100β protein and neuron-specific enolase (NSE) levels	Preoperative and postoperative days 1 and 2
The duration of POD	within the first 7 postoperative days	The total number of days with positive results.

Trial Locations

Locations (1)

The First Affiliated Hospital of Air Force Medical University; 🇨🇳 Xi'an, Shanxi, China