Impact of Multimodal Brain Monitoring Under General Anesthesia on Postoperative Outcomes in Elderly Patients Undergoing Major Abdominal Surgery: A Multicenter, Prospective, Single-blind, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 368
- 试验地点
- 4
- 主要终点
- Incidence of Postoperative Composite Complication
研究概览
简要总结
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:
- Undergo routine preoperative fasting for 6-8 hours;
- Prior to anesthesia induction, cooperate with the establishment of intravenous access, arterial catheterization, monitoring of physiological parameters, blood sample collection, and receive fluid preloading;
- During surgery, for patients in the MBMGA group , propofol and remifentanyl will be adjusted according to multimodal brain monitoring indices (WLi and PTi), while for patients in the BIS group, only propofol will be adjusted based on bispectral index and remifentanyl will be adjusted according to anesthesiologists' experience; simultaneously, vital signs, including respiration, body temperature, fluid therapy, blood pressure, and heart rate regulation, will be monitored and managed.
- After surgery, endotracheal tubes will be removed once extubation criteria are met, and patients will be transferred to the PACU, where they will receive routine monitoring and will be discharged from the PACU upon meeting corresponding scoring criteria;
- Participates in follow-ups on the day of surgery and for 1-30 days postoperatively, during which investigators will record the primary outcome and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Postoperative Composite Complication
时间窗: From post-extubation to postoperative Day 30
The incidence of ≥ 1 complication occurred from the extubation to the 30 th day postoperatively The definition of postoperative composite complications refers to the rate of occurrence of one or more complications from the time of anesthesia extubation to postoperative day 7 (or the day of discharge) and within 30 days after surgery. Postoperative complications are defined as adverse events of Clavien Dindo grade II or higher occurring in any system from postoperative day 1 to day 7 (or the day of discharge) and within 30 days after surgery.
次要结局
- Incidence of intraoperative stress-induced hyperglycemia(From anesthesia induction to skin closure, assessed up to 5 minutes after surgery)
- Incidence of intraoperative composite adverse events(during operation, assessed up to 5 minutes after surgery)
- Blood pressure change immediately after intubation(at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation)
- Duration of intraoperative hypotension(From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery)
- Total pintraoperative anesthetic/vasoactive drug dosages(from the anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery)
- Serum cortisol levels before surgery and 24 hours postoperatively(From before surgery and 24 hours post-operation)
- Durations from drug cessation to awake/extubation(From drug cessation to awake/extubation , assessed up to 2 hours after entering post-anesthsia care unit)
- Rate of postoperative Intensive Care Unit/Anesthesia Intensive Care Unit transfer(From the end of surgery to Discharge, assessed up to 2 weeks after surgery)
- Duration to first patient controlled intravenous analgesia pump use(From the initiation of patient controlled intravenous analgesia pump use to the discontinuation of analgesic pump use, assessed up to 3 days after surgery)
- Incidence of complications in other organ systems during the follow-up period except stress induced hyperglycemia(From the start of surgery to 30 days post-operation)
- Length of hospital stay(From patient admission to discharge, assessed up to 2 weeks after surgery)
- Rate of second operation(From immediately after surgery to 30 days postoperatively)
- Mortality within 30-day postoperatively(From immediately after surgery to 30 days postoperatively)
- Incidence of acute myocardial injury(From anesthesia induction to 24 hours after surgery)
- Incidence of acute kidney injury(From anesthesia induction to 24 hours after surgery)
- Incidence of postoperative surgical site infection(From immediately after surgery to 30 days postoperatively)
- Heart rate change immediately after intubation(at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation)
- Duration to postoperative first flatus time(From the end of surgery to 7 days after surgery)
- Duration to postoperative first oral intake(From the end of surgery to 7 days after surgery)
- Minimum intraoperative mean arterial pressure(From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery)
- Incidence of hypotension.(From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery)
- Durations of post-anesthesia care unit stay(From entering post-anesthesia care unit to post-anesthesia care unit discharge, assessed up to 2 hours after entering post-anesthsia care unit)
- Cumulative postoperative oxycodone dosage(From the initiation of patient controlled intravenous analgesia pump use to the discontinuation of analgesic pump use, assessed up to 3 days after surgery)
- The duration of intraoperative deep sedation(from anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery)
- The duration of intraoperative inadequate analgesia(from anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery)
- Scores of Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms at 72 hours after surgery(at 72 hours after surgery)