postoperative pain and postoperative neurocognitive disorders
Conditions
Interventions
Control group : Mild Analgesia Group(PTi=65±5):Following successful induction of anesthesia, a remifentanil infusion was initiated at 0.15 µg/kg/min. The infusion rate was then titrated in increments
Intervention Group: Deep Analgesia Group (PTi=50±5):Following successful induction of anesthesia, a remifentanil infusion was initiated and titrated to achieve a target Pain Threshold Index (PTi) of 5
Sponsors
Hebei Hospital of Xuanwu Hospital of Capital Medical University (The First Hospital of Hebei Medical university)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=60 years old; 2.Patients scheduled for elective spinal fusion surgery involving no more than 5 levels; 3. American Society of Anesthesiologists (ASA) grade I.~III; 4. Planned intravenous anesthesia (TIVA) anesthesia; 5. Right-handed: Edinburgh Hand Hand Questionnaire (EHI)> 40; 6. Be ethical and voluntarily participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Traumatic spinal fractures with multiple organ/tissue open trauma; 2. Previous history of anesthetic drug allergy and/or major anesthesia surgery within three months; 3. History of previous psychiatric/neurological diseases (including anxiety disorders, depression, long-term insomnia, AD, Parkinson's, etc.), or long-term use of psychiatric drugs (including anxiolytic/depressive drugs, analgesics/sleeping drugs, etc.), antiepileptic drugs, and history of drug and/or alcohol abuse, etc.; 4. Presence of delirium, obvious cognitive dysfunction or dementia before surgery (MoCA-B screening: illiteracy, primary school <= 17 points, middle school (including technical secondary school) <= 20 points, university (including junior secondary school) < = 24 points; MMSE screening: Chinese blind <= 17 points, primary school <= 20 points, middle school (including technical secondary school) <= 22 points, university (including junior college) <= 23 points), or audio-visual dysfunction cannot cooperate with scale assessment; 5. Previous stroke history with sequelae, brain structural abnormalities or head trauma surgery; 6. History of severe cardiovascular disease, severe liver, kidney and lung dysfunction, abnormal thyroid function, and abnormal adrenal cortex function; 7. Contraindications to MRI scanning or inability to cooperate with MRI scanning; 8. Participated in other drug clinical trials as a subject in the past 3 months; 9. Other conditions that the investigator deems unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Delayed neurocognitive recovery (dNCR);Acute postoperative pain (APSP);Brain MRI indexs (Including the whole brain, pain-related brain regions, and cognition-related brain regions);Perioperative prefrontal electroencephalographic (EEG) indexs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory biomarkers;Stress biomarkers;Neural Injury Biomarkers;Perioperative medication use (including anesthetic agents, vasoactive drugs, anti-inflammatory medications, and postoperative analgesics with rescue analgesia details);Postoperative neurocognitive Disorder;Postoperative Complications;Postoperative Recovery Outcomes;Chronic Postoperative Pain;Demographics, baseline characteristics and anesthetic and surgical characteristics;Intraoperative Fluid Intake and Output;Postoperative delirium (POD);N-back task metrics (including average response time and accuracy rate); | — |
Countries
China
Contacts
Public ContactTianlong Wang
Hebei Hospital of Xuanwu Hospital of Capital Medical University (The First Hospital of Hebei Medical university)
Outcome results
None listed