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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital of Air Force Medical University
RECRUITING
Xi’an
Contact Information
Primary
Huang Nie
niehuang@163.com
+86 13201630298
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 450
Treatments
Experimental: TIVA
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.
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov

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