The Impact of Multimodal Brain Monitoring on Postoperative Outcomes in Elderly Patients Undergoing Major Abdominal Surgery

Condition(s) studied

Investigational drug(s) / intervention(s)

Multimodal brain monitoring guided anesthesia: During the anesthesia induction phase, the dosage administration is guided by the goal of reducing PTi to the range of 40-70, and tracheal intubation is performed when both PTi and WLI are within 40-70. In the anesthesia maintenance phase, the propofol dosage is adjusted according to the WLI value to maintain WLI within 40-70, while the remifentanil dosage is adjusted based on the PTi value to keep PTi within 40-70. In the event of sudden increased intraoperative pain stimulation (PTi \> 70) accompanied by tachycardia and hypertension, an intravenous bolus of remifentanil at 0.5-1 μg/kg is administered; after 1 minute of observation, if PTi remains \> 70, an additional 0.5-1 μg/kg of remifentanil is given until PTi is brought back to the 40-70 range.

Bispectral Index(BIS) monitoring guided anesthesia: During the anesthesia induction phase, the dosage administration is guided by the goal of reducing BIS to the range of 40-60, with remifentanil supplemented based on clinical experience. In the anesthesia maintenance phase, the propofol dosage is adjusted according to BIS values to maintain BIS within 40-60, while the remifentanil dosage is adjusted based on anesthesiologists' experience. When there is a high suspicion of sudden tachycardia and hypertension induced by increased intraoperative pain stimulation, an intravenous bolus of remifentanil at 0.5-1 μg/kg is administered; after 1 minute of observation, if heart rate and blood pressure show no improvement, an additional 0.5-1 μg/kg of remifentanil is given until there is a downward trend in heart rate and blood pressure and they return to pre-stimulation levels.

Study summary

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:

1. Undergo routine preoperative fasting for 6-8 hours;
2. Prior to anesthesia induction, cooperate with the establishment of intravenous access, arterial catheterization, monitoring of physiological parameters, blood sample collection, and receive fluid preloading;
3. 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.
4. 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;
5. 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.

Eligibility

Primary outcome measure(s)

• Incidence of Postoperative Composite Complication — 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.

Trial sites (4)

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