Anesthesia, General, Major Abdominal Surgeries
Conditions
Brief 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.
Interventions
OTHERMultimodal 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.
OTHERBispectral 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.
Sponsors
Xuanwu Hospital, Beijing
Tongji Hospital
Peking University International Hospital
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative stress-induced hyperglycemia | From anesthesia induction to skin closure, assessed up to 5 minutes after surgery | 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. |
| Incidence of intraoperative composite adverse events | during operation, assessed up to 5 minutes after surgery | 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) |
| Blood pressure change immediately after intubation | at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation | Record blood pressure before induction and immediately after completion of intubation, and calculate the magnitude of change. |
| Duration of intraoperative hypotension | From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery | 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. |
| Total pintraoperative anesthetic/vasoactive drug dosages | from the anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery | 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 |
| Serum cortisol levels before surgery and 24 hours postoperatively | From before surgery and 24 hours post-operation | Measure serum cortisol concentrations at the following time points: Preoperatively and 24 hours postoperatively |
| Durations from drug cessation to awake/extubation | From drug cessation to awake/extubation , assessed up to 2 hours after entering post-anesthsia care unit | Duration from anesthesia discontinuation to awake and duration from anesthesia discontinuation to extubation |
| 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 | 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. |
| 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 | The duration from the end of surgery until the first activation of the patient controlled intravenous analgesia pump |
| 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 | 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. |
| Length of hospital stay | From patient admission to discharge, assessed up to 2 weeks after surgery | the duration of patient stay in hospital |
| Rate of second operation | From immediately after surgery to 30 days postoperatively | Observation and record the rate of secondary surgeries |
| Mortality within 30-day postoperatively | From immediately after surgery to 30 days postoperatively | Record the mortality within 30 days postoperatively. |
| Incidence of acute myocardial injury | From anesthesia induction to 24 hours after surgery | 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 |
| Incidence of acute kidney injury | From anesthesia induction to 24 hours after surgery | 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. |
| Incidence of postoperative surgical site infection | From immediately after surgery to 30 days postoperatively | 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. |
| Heart rate change immediately after intubation | at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation | Record heart rate before induction and immediately after completion of intubation, and calculate the magnitude of change. |
| Duration to postoperative first flatus time | From the end of surgery to 7 days after surgery | Duration to postoperative first flatus time |
| Duration to postoperative first oral intake | From the end of surgery to 7 days after surgery | Duration to postoperative first oral intake |
| Minimum intraoperative mean arterial pressure | From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery | Parameters to be recorded: Minimum intraoperative mean arterial pressure ； |
| Incidence of hypotension. | From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery | 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. |
| 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 | Duration of post-anesthesia care unit stay |
| 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 | Cumulative postoperative oxycodone dose |
| 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 wavelet index below 40 or Bispectral Index below 40 |
| The duration of intraoperative inadequate analgesia | from anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery | The duration of intraoperative pain threshold index higher than 70 |
| Scores of Intake, Feeling nauseated, Emesis, physical Exam, and Duration of symptoms at 72 hours after surgery | 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. |
Countries
China
Contacts
CONTACTTianlong Wang, Doctor
CONTACTWei Xiao, Doctor
PRINCIPAL_INVESTIGATORTianlong Wang, Doctor
Xuanwu Hospital, Beijing
Outcome results
None listed