About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥60 years
Elective surgery (with an expected duration of 2 hours or more)
ASA grade Ⅰ-Ⅲ
Voluntary participation and informed consent obtained
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
TIVA ( anesthesia with propofol and remifentanil)
DrugParticipants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery
VA(anesthesia with sevoflurane and remifentanil)
DrugParticipants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
The severity of POD
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 duration of POD
The total number of days with positive results.
The length of hospital stay
Blood glucose levels
During the surgery, bedside capillary blood glucose levels will be measured using a portable blood glucose meter (capillary blood).
Other outcomes
Serum insulin levels
Serum inflammatory factor (IL-6) levels
Serum neurodegenerative factor (S-100β protein) levels
Sponsors and contacts
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