Impact of Sevoflurane Versus Propofol on Postoperative Delirium in Elderly Diabetic Patients Undergoing Non-Cardiac Surgery: a Multicenter, Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TIVA ( anesthesia with propofol and remifentanil), VA（anesthesia with sevoflurane and remifentanil）.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium (POD), Diabetes. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- the incidence of delirium [Time frame: within the first 7 postoperative days]
Secondary outcome measures (4)
- The severity of POD [Time frame: within the first 7 postoperative days]
- The duration of POD [Time frame: within the first 7 postoperative days]
- The length of hospital stay [Time frame: 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- The First Affiliated Hospital of Air Force Medical University — Xi’an
Identifiers
NCT: NCT06788743 · NCT06788743