Diabetes, Postoperative Delirium (POD)
Conditions
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. 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
DRUGTIVA ( anesthesia with propofol and remifentanil)
Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery
DRUGVA（anesthesia with sevoflurane and remifentanil）
Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery.
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 duration of POD | within the first 7 postoperative days | The total number of days with positive results. |
| The length of hospital stay | the first 7 postoperative days | — |
| Blood glucose levels | 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) | During the surgery, bedside capillary blood glucose levels will be measured using a portable blood glucose meter (capillary blood). |
Countries
China
Outcome results
None listed