Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVA | Experimental | Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery |
|
| VA | Experimental | Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVA ( anesthesia with propofol and remifentanil) | Drug | Participants assigned to the TIVA group will receive propofol combined with remifentanil for anesthesia maintenance during the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | within the first 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | within the first 7 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Serum insulin levels | at 1 h and 2 h after incision(T1, T2) | |
| Serum inflammatory factor (IL-6) levels | post-operative days 1 and 2 (T5, T6) | |
| Serum neurodegenerative factor (S-100β protein) levels |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huang Nie | Contact | +86 13201630298 | niehuang@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Air Force Medical University | Recruiting | Xi’an | Shanxi | 710032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| VA(anesthesia with sevoflurane and remifentanil) | Drug | Participants assigned to the VA group will receive sevoflurane combined with remifentanil for anesthesia maintenance during the surgery. |
|
| The duration of POD |
The total number of days with positive results. |
| within the first 7 postoperative days |
| The length of hospital stay | the first 7 postoperative days |
| Blood glucose levels | During the surgery, bedside capillary blood glucose levels will be measured using a portable blood glucose meter (capillary blood). | 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) |
| post-operative days 1 and 2 (T5, T6) |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D015742 | Propofol |
| D000077208 | Remifentanil |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided