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

NCT ID: NCT06788743

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Delirium (POD) Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TIVA

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

Group Type EXPERIMENTAL

TIVA ( anesthesia with propofol and remifentanil)

Intervention Type DRUG

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

VA

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

Group Type EXPERIMENTAL

VA(anesthesia with sevoflurane and remifentanil)

Intervention Type DRUG

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

Interventions

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TIVA ( anesthesia with propofol and remifentanil)

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Air Force Medical University

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huang Nie

Role: CONTACT

+86 13201630298

Facility Contacts

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Jiangru Kang

Role: primary

Other Identifiers

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NCT06788743

Identifier Type: -

Identifier Source: org_study_id

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