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

NCT07713355 | Not Yet Recruiting DMC

• 1 other identifier: Linyanshen[2025]075-004-xz-1
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 4

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. 1.Undergo routine preoperative fasting for 6-8 hours;
2. 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. 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. 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. 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.

Conditions

Anesthesia, General; Major Abdominal Surgeries

Outcome Measures

Primary Outcomes (1)

• 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.

  From post-extubation to postoperative Day 30

Secondary Outcomes (26)

• 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

Study Arms (2)

Multimodal Brain Monitoring Guided Anesthesia Group(MBMGA Group)

EXPERIMENTAL

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.

Other: Multimodal brain monitoring guided anesthesia

Bispectral Index (BIS) Monitoring Guided Anesthesia Group( BIS Group)

ACTIVE COMPARATOR

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.

Other: Bispectral Index(BIS) monitoring guided anesthesia

Interventions

Multimodal brain monitoring guided anesthesia OTHER

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.

Multimodal Brain Monitoring Guided Anesthesia Group(MBMGA Group)

Bispectral Index(BIS) monitoring guided anesthesia OTHER

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.

Bispectral Index (BIS) Monitoring Guided Anesthesia Group( BIS Group)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Tongji Hospital: collaborator
• Peking University International Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (4)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 10053, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Related Publications (17)

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Study Officials

• Tianlong Wang, Doctor

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianlong Wang, Doctor

CONTACT

0086139 1052 5304; w_tl5595@hotmail.com

Wei Xiao, Doctor

CONTACT

008613810971299; kitten15@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after results publicated
• Access Criteria: Contacting the corresponsible author.

Locations

CN (4)