The purpose of this clinical trial is to investigate the effect of multimodal brain monitoring under general anesthesia on postoperative outcomes in elderly patients undergoing abdominal surgery.The research hypothesis is that multimodal brain monitoring under general anesthesia can reduce the incidence of postoperative composite complications and improve postoperative outcomes in elderly patients undergoing major abdominal surgery.
Eligible patients will be randomly assigned in a 1:1 ratio to the Multimodal Brain Monitoring under General Anesthesia Group (MBMGA group) and the Bispectral Index Monitoring under General Anesthesia Group (BIS group). The primary outcome is the postoperative composite complication rate . Secondary outcomes include intraoperative hyperglycemia, adverse events during anesthesia induction and maintanance, changes in blood pressure and heart rate, intraoperative hypotension, the dosage of perioperative anesthetics and vasoactive drugs, changes in serum cortisol, cardiac troponin I, blood creatinine (Cr) level, extubation time and awake time, the rate of transferring to ICU or AICU, The time to first use analgesia pump and the cumulative dose of postoperative oxycodone, systemic complications, hospitalization time, first exhaust time , first oral intake time, rate of second surgery and mortality within 30 days postoperatively.
Participants will:
Inclusion Criteria:
Aged ≥65 years, regardless of gender; Scheduled for elective abdominal surgery with general anesthesia duration (from anesthesia induction to surgery completion) ≥ 2 hours; American Society of Anesthesiologists (ASA) physical status classification of I-III; Body mass index (BMI) of 18.5-29.9 kg/m²; Postoperative hospital stay expected to exceed 72 hours; Compliant with ethical standards, with voluntary signed informed consent.
Exclusion Criteria:
Severe cardiovascular diseases, including:
History of myocardial infarction within the past 6 months; Bradycardia (resting heart rate <50 beats/min); Uncontrolled hypertension (sitting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during screening); Sitting systolic blood pressure ≤90 mmHg during screening; History of severe valvular heart disease; Uncontrolled severe respiratory infections: e.g., severe pneumonia, acute bronchitis.
Abnormal liver function: Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) ≥2.5×Upper Limit of Normal (ULN), Total Bilirubin (TBIL) ≥1.5×Upper Limit of Normal (ULN); Abnormal renal function: urea or blood urea nitrogen (BUN) ≥1.5×Upper Limit of Normal (ULN), serum creatinine >Upper Limit of Normal (ULN); Admission hemoglobin A1c (HbA1c) ≥6.5% or ≥2 fasting blood glucose measurements ≥180 mg/dl (10 mmol/L) and/or random blood glucose ≥200 mg/dL (≈11.1 mmol/L); Preoperative anemia (Hemoglobin [Hb] ≤90 g/L), thrombocytopenia (Platelet [PLT] ≤80×10⁹/L), hypoproteinemia (Albumin [Alb] ≤30 g/L); History of drug abuse and/or alcoholism within the past 2 years (alcoholism defined as daily average alcohol consumption >2 units, where 1 unit = 360 mL beer or 45 mL 40% ethanol liquor or 150 mL wine); Neurological diseases (e.g., stroke within 6 months, Alzheimer's disease, Parkinson's disease, mental disease, myasthenia gravis) or psychiatric disorders (e.g., schizophrenia, mania, bipolar disorder, delirium), history of long-term use of neuropsychiatric medications, or cognitive impairment; Allergy or contraindication to study medications; Patients refusing or unable to cooperate with the study; Scheduled for pancreatic surgery; Other conditions deemed inappropriate for participation by the investigator.
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The dosage of propofol is adjusted to maintain WLi in the range of 40-70. While the dosage of remifentanil is adjusted to maintain PTi in the range of 40-70. When intraoperative pain stimulation suddenly increases ( PTi \> 70 ) and lead to increased heart rate and elevated blood pressure, remifentanil 0.5-1 μg / kg will be intravenously injected and observed for 1 min. If PTi still is \> 70, remifentanil 0.5-1 μg / kg will be added again until PTi reached 40-70.
The dosage of propofol is adjusted according to the value of BIS, and the BIS is maintained in the range of 40 \~ 60. The dosage of remifentanil is adjusted according to the experience of anesthesiologists. The intraoperative remifentanil dosage will be maintained between 0.1 μg/kg/min and 0.3μg/kg/min.When it is highly suspected that the sudden increase of pain stimulation during operation leads to the increase of heart rate and blood pressure, remifentanil 0.5 \~ 1 μg / kg will be given intravenously for 1 min. If the heart rate and blood pressure level don't improve, remifentanil 0.5 \~ 1 μg / kg is added again until the heart rate and blood pressure have a downward trend and return to the level before the increase.
kitten15@126.com008613810971299
Beijing, Beijing Municipality 10053, China
kitten15@126.com008613810971299
yaolan@pkuih.edu.cn008613671010819
jianjunyang1971@163.com008613357739238
alluo@tjh.tjmu.edu.cn008613507122565
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