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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
368
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.
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.
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei, China
Incidence of Postoperative Composite Complication
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.
Time frame: From post-extubation to postoperative Day 30
Incidence of intraoperative stress-induced hyperglycemia
Intraoperative stress hyperglycemia is defined as: A condition diagnosed when a patient meeting all the following criteria: Preoperative glycemic status: Two or more fasting blood glucose measurements \< 126 mg/dL (≈7.0 mmol/L) or Random blood glucose \< 200 mg/dL (≈11.1 mmol/L) during hospitalization, With concurrent HbA1c \< 6.5%; Intraoperative finding: Highest blood glucose level ≥ 140 mg/dL (≈7.8 mmol/L) when measured at: 1 hour after intubation and/or Upon completion of surgery.
Time frame: From anesthesia induction to skin closure, assessed up to 5 minutes after surgery
Incidence of intraoperative composite adverse events
Observe and record the incidence of intraoperative composite adverse events . Adverse events include but are not limited to: 1. Cardiovascular Complications: * Hypotension * Hypertension * Severe Arrhythmia ④Acute Myocardial Ischemia * Acute Myocardial Infarction ⑥Acute Pulmonary Embolism * Acute Heart Failure ⑧Deep Vein Thrombosis 2. Respiratory Complications: * Pneumonia * Acute Respiratory Distress Syndrome (ARDS) * Pulmonary Edema ④Respiratory Failure ⑤Bronchospasm ⑥Atelectasis ⑦Pleural Effusion 3. Neurological Complications: ①Intraoperative Awareness ②Acute Stroke 4. Renal Complications: * Acute Kidney Injury (AKI) ②Acute Renal Failure (ARF)
Time frame: during operation, assessed up to 5 minutes after surgery
Blood pressure change immediately after intubation
Record blood pressure before induction and immediately after completion of intubation, and calculate the magnitude of change.
Time frame: at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation
Duration of intraoperative hypotension
Parameters to be recorded: Duration of intraoperative hypotension； Hypotension is defined as: Mean arterial pressure \< 65 mmHg or decrease of mean arterial pressure \> 20% from preoperative baseline value.
Time frame: From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery
Total pintraoperative anesthetic/vasoactive drug dosages
Record the dosages of all medications administered during the intraoperative period, including but not limited to: General anesthetics: Propofol, Remifentanil, Sufentanil, Oxycodone Vasoactive agents: * Norepinephrine * Esmolol * Urapidil * Atropine * Ephedrine * Phenylephrine
Time frame: 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
Measure serum cortisol concentrations at the following time points: Preoperatively and 24 hours postoperatively
Time frame: From before surgery and 24 hours post-operation
Durations from drug cessation to awake/extubation
Duration from anesthesia discontinuation to awake and duration from anesthesia discontinuation to extubation
Time frame: 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
The ratio of postoperative patients requiring transfer to either the Anesthesia Intensive Care Unit or Intensive Care Unit for any clinical indication, to the total number of surgical patients during the same period.
Time frame: From the end of surgery to Discharge, assessed up to 2 weeks after surgery
Duration to first patient controlled intravenous analgesia pump use
The duration from the end of surgery until the first activation of the patient controlled intravenous analgesia pump
Time frame: 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
Follow-up assessments will be performed by a single blinded and certified anesthesia practitioner at postoperative days 1-7 and day 30, with documentation of complications involving: Cardiovascular system； Respiratory system； Digestive system； Nervous system； Urinary system； Infection-related complications,such as wound infection 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.
Time frame: From the start of surgery to 30 days post-operation
Length of hospital stay
the duration of patient stay in hospital
Time frame: From patient admission to discharge, assessed up to 2 weeks after surgery
Rate of second operation
Observation and record the rate of secondary surgeries
Time frame: From immediately after surgery to 30 days postoperatively
Mortality within 30-day postoperatively
Record the mortality within 30 days postoperatively.
Time frame: From immediately after surgery to 30 days postoperatively
Incidence of acute myocardial injury
Measure blood cardiac troponin I level at the following time points: Preoperatively and 24 hours postoperatively, measurement of cardiac troponin I exceeds the 99th percentile upper reference limit
Time frame: From anesthesia induction to 24 hours after surgery
Incidence of acute kidney injury
Measure blood creatinine level at the following time points: 1 day before surgery, and 24 hours postoperatively;Acute kidney injury was defined according to the KDIGO criteria as the presence of any of the following: (1) an increase in serum creatinine by ≥26.5 μmol/L (0.3 mg/dL) within 48 hours; (2) an increase in serum creatinine to ≥1.5 times baseline within the previous 7 days; or (3) a urine volume \<0.5 mL/kg/h for 6 consecutive hours.
Time frame: From anesthesia induction to 24 hours after surgery
Incidence of postoperative surgical site infection
surgical site infection refers to the proportion of surgical cases with surgical site infection (SSI) occurring from after surgery to before discharge, relative to the total number of surgical procedures performed on hospitalized patients during the same period. Postoperative wound infection is defined as an infection related to the surgical procedure and occurring near the surgical site within 30 days after surgery. Postoperative wound infections include: superficial incisional SSI, deep incisional SSI, and organ/space SSI.
Time frame: From immediately after surgery to 30 days postoperatively
Heart rate change immediately after intubation
Record heart rate before induction and immediately after completion of intubation, and calculate the magnitude of change.
Time frame: at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation
Duration to postoperative first flatus time
Duration to postoperative first flatus time
Time frame: From the end of surgery to 7 days after surgery
Duration to postoperative first oral intake
Duration to postoperative first oral intake
Time frame: From the end of surgery to 7 days after surgery
Minimum intraoperative mean arterial pressure
Parameters to be recorded: Minimum intraoperative mean arterial pressure ；
Time frame: From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery
Incidence of hypotension.
Parameters to be recorded: Incidence of hypotension； Hypotension is defined as: Mean arterial pressure \< 65 mmHg or decrease of mean arterial pressure \> 20% from preoperative baseline value.
Time frame: From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery
Durations of post-anesthesia care unit stay
Duration of post-anesthesia care unit stay
Time frame: 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
Cumulative postoperative oxycodone dose
Time frame: 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
The duration of intraoperative wavelet index below 40 or Bispectral Index below 40
Time frame: from anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery
The duration of intraoperative inadequate analgesia
The duration of intraoperative pain threshold index higher than 70
Time frame: 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
Scores of Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms at 72 hours after surgery, Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms is a scoring system to evaluate the postoperative gastrointestinal function, if the score is higher than 6, it indicating gastrointestinal dysfunction.
Time frame: at 72 hours after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.