Anesthesia, GeneralNCT07713355
The Impact of Multimodal Brain Monitoring on Postoperative Outcomes in Elderly Patients Undergoing Major Abdominal Surgery
A study testing Multimodal brain monitoring guided anesthesia and Bispectral Index(BIS) monitoring guided anesthesia in people with Anesthesia, General and Major Abdominal Surgeries, run by Xuanwu Hospital, Beijing at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anesthesia, General, Major Abdominal Surgeries
- What is being tested?
- Multimodal brain monitoring guided anesthesia and Bispectral Index(BIS) monitoring guided anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 4 sitesChina
- Study dates
- 1 Aug 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 10053
Wei Xiao, Doctor, 008613810971299, kitten15@126.com
Tianlong Wang
Peking University International Hospital
Beijing, Beijing Municipality
Lan Yao, Doctor, 008613671010819, yaolan@pkuih.edu.cn
Lan Yao
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
Wuhan, Hubei
Ailin Luo, Doctor, 008613507122565, alluo@tjh.tjmu.edu.cn
Ailin Luo
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Jianjun Yang, Doctor, 008613357739238, jianjunyang1971@163.com
Jianjun Yang
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Anesthesia, General, Major Abdominal Surgeries
- Being tested
- Multimodal brain monitoring guided anesthesia, Bispectral Index(BIS) monitoring guided anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal brain monitoring guided anesthesiaOther
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 anesthesiaOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Bispectral Index(BIS) monitoring guided anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From post-extubation to postoperative Day 30
Secondary outcomes (26)
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.
Measured: 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:
- Cardiovascular Complications:
- Hypotension
- Hypertension
- Severe Arrhythmia ④Acute Myocardial Ischemia
- Acute Myocardial Infarction ⑥Acute Pulmonary Embolism
- Acute Heart Failure ⑧Deep Vein Thrombosis
- Respiratory Complications:
- Pneumonia
- Acute Respiratory Distress Syndrome (ARDS)
- Pulmonary Edema ④Respiratory Failure ⑤Bronchospasm ⑥Atelectasis ⑦Pleural Effusion
- Neurological Complications: ①Intraoperative Awareness ②Acute Stroke
- Renal Complications:
- Acute Kidney Injury (AKI) ②Acute Renal Failure (ARF)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: From the start of surgery to 30 days post-operation
Length of hospital stay
the duration of patient stay in hospital
Measured: From patient admission to discharge, assessed up to 2 weeks after surgery
Rate of second operation
Observation and record the rate of secondary surgeries
Measured: From immediately after surgery to 30 days postoperatively
Mortality within 30-day postoperatively
Record the mortality within 30 days postoperatively.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From the end of surgery to 7 days after surgery
Duration to postoperative first oral intake
Duration to postoperative first oral intake
Measured: From the end of surgery to 7 days after surgery
Minimum intraoperative mean arterial pressure
Parameters to be recorded:
Minimum intraoperative mean arterial pressure ；
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: at 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Peking University International Hospital, The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Sponsor
- Investigators
- Tianlong Wang, Doctor, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713355
- Sponsor's protocol ID
- Linyanshen[2025]075-004-xz-1
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
American Diabetes Association Professional Practice Committee. 16. Diabetes Care in the Hospital: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S321-S334. doi: 10.2337/dc25-S016.
PubMed 39651972You J, Chen X, Rong Y, Pan S, Liu T, Xie Y. Application value of different frailty assessment tools in older patients undergoing major abdominal surgery. Exp Gerontol. 2025 Oct 1;209:112852. doi: 10.1016/j.exger.2025.112852. Epub 2025 Jul 29.
PubMed 40744366Trocheris-Fumery O, Flet T, Scetbon C, Tarpin P, Meynier J, Badaoui R, De Broca B, Sabbagh C, Regimbeau JM, De Sousa P, Foulon A, Josse E, Dupont H, Bar S, Abou-Arab O. Early Use of Norepinephrine in High-risk Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial. Anesthesiology. 2025 Nov 1;143(5):1160-1170. doi: 10.1097/ALN.0000000000005704. Epub 2025 Aug 4.
PubMed 40758953Zhang Y, Yan R, Kurexi A, Yuan T, Taati Z, Mijiti M, Li D, Wei F. The relationship between preoperative SPPB scores and 30-day postoperative pulmonary complications in elderly patients undergoing elective major abdominal surgery. BMC Surg. 2025 Oct 28;25(1):507. doi: 10.1186/s12893-025-03260-6.
PubMed 41152837Bieze M, McGinn R, Berrio-Valencia M, Talarico R, Martel G, McCluskey SA, McIsaac DI. Temporal trends in postoperative outcomes after major abdominal surgery: a population-based cohort study. Br J Anaesth. 2026 Jan;136(1):237-246. doi: 10.1016/j.bja.2025.08.030. Epub 2025 Oct 23.
PubMed 41136320Gameiro J, Neves JB, Rodrigues N, Bekerman C, Melo MJ, Pereira M, Teixeira C, Mendes I, Jorge S, Rosa R, Lopes JA. Acute kidney injury, long-term renal function and mortality in patients undergoing major abdominal surgery: a cohort analysis. Clin Kidney J. 2016 Apr;9(2):192-200. doi: 10.1093/ckj/sfv144. Epub 2016 Jan 18.
PubMed 26985368Teixeira C, Rosa R, Rodrigues N, Mendes I, Peixoto L, Dias S, Melo MJ, Pereira M, Bicha Castelo H, Lopes JA. Acute kidney injury after major abdominal surgery: a retrospective cohort analysis. Crit Care Res Pract. 2014;2014:132175. doi: 10.1155/2014/132175. Epub 2014 Feb 24.
PubMed 24719758Zhang W, Cheng Y, Zhang L, Wei Y, Xie H, Huang J. Association between emergence delirium and brain status parameters in children undergoing general anesthesia: A prospective observational study. Paediatr Anaesth. 2024 Feb;34(2):130-137. doi: 10.1111/pan.14779. Epub 2023 Oct 3.
PubMed 37788105Zhang JW, Lv ZG, Kong Y, Han CF, Wang BG. Wavelet and pain rating index for inhalation anesthesia: A randomized controlled trial. World J Clin Cases. 2020 Nov 6;8(21):5221-5234. doi: 10.12998/wjcc.v8.i21.5221.
PubMed 33269258Funcke S, Pinnschmidt HO, Wesseler S, Brinkmann C, Beyer B, Jazbutyte V, Behem CR, Trepte C, Nitzschke R. Guiding Opioid Administration by 3 Different Analgesia Nociception Monitoring Indices During General Anesthesia Alters Intraoperative Sufentanil Consumption and Stress Hormone Release: A Randomized Controlled Pilot Study. Anesth Analg. 2020 May;130(5):1264-1273. doi: 10.1213/ANE.0000000000004388.
PubMed 31517677Wu L, Wang S, Wang Y, Zhang K, Bai J, Zheng J. Prediction of Hemodynamic Reactivity by Electroencephalographically Derived Pain Threshold Index in Children Undergoing General Anesthesia: A Prospective Observational Study. J Pain Res. 2019 Dec 3;12:3245-3255. doi: 10.2147/JPR.S231596. eCollection 2019.
PubMed 31819608Shen H, Wang S, Zhang C, Gao W, Cui X, Zhang Q, Lang Y, Ning M, Li T. Association of hyperglycemia ratio and ventricular arrhythmia in critically ill patients admitted to the intensive care unit. BMC Cardiovasc Disord. 2023 Apr 28;23(1):215. doi: 10.1186/s12872-023-03208-9.
PubMed 37118670Yu Y, Wang H, Wei L, Gao Y, Yan N, Chu J, Li H. Assessing the use of the Index of Consciousness (IoC) as a monitoring tool for the sedative effects of ciprofol during general anesthesia induction: a prospective observational study. Perioper Med (Lond). 2025 Jan 6;14(1):1. doi: 10.1186/s13741-024-00484-7.
PubMed 39762970Chung CKE, Poon CCM, Irwin MG. Peri-operative neurological monitoring with electroencephalography and cerebral oximetry: a narrative review. Anaesthesia. 2022 Jan;77 Suppl 1:113-122. doi: 10.1111/anae.15616.
PubMed 35001382Fu G, Xu L, Chen H, Lin J. State-of-the-art anesthesia practices: a comprehensive review on optimizing patient safety and recovery. BMC Surg. 2025 Jan 20;25(1):32. doi: 10.1186/s12893-025-02763-6.
PubMed 39833810
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07713355
- Acronym / sponsor ID
- Linyanshen[2025]075-004-xz-1
- Conditions
- Anesthesia, General, Major Abdominal Surgeries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Tongji Hospital, Peking University International Hospital, The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Brain Monitoring Guided Anesthesia Group(MBMGA Group) | Experimental | Other: Multimodal brain monitoring guided anesthesiaThe 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. |
| Bispectral Index (BIS) Monitoring Guided Anesthesia Group( BIS Group) | Active comparator | Other: Bispectral Index(BIS) monitoring guided anesthesiaThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal brain monitoring guided anesthesiaDuring 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. | Other | Multimodal Brain Monitoring Guided Anesthesia Group(MBMGA Group) |
| Bispectral Index(BIS) monitoring guided anesthesiaDuring 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. | Other | Bispectral Index (BIS) Monitoring Guided Anesthesia Group( BIS Group) |
Primary outcome
Incidence of Postoperative Composite Complication
Time frame: 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.
26 secondary outcomes
Incidence of intraoperative stress-induced hyperglycemia
Time frame: From anesthesia induction to skin closure, assessed up to 5 minutes after surgery
Incidence of intraoperative composite adverse events
Time frame: during operation, assessed up to 5 minutes after surgery
Blood pressure change immediately after intubation
Time frame: at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation
Duration of intraoperative hypotension
Time frame: From the anesthesia induction to the end of surgery, assesed up to 5 minutes after surgery
Total pintraoperative anesthetic/vasoactive drug dosages
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
Time frame: From before surgery and 24 hours post-operation
Durations from drug cessation to awake/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
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
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
Time frame: From the start of surgery to 30 days post-operation
Length of hospital stay
Time frame: From patient admission to discharge, assessed up to 2 weeks after surgery
Rate of second operation
Time frame: From immediately after surgery to 30 days postoperatively
Mortality within 30-day postoperatively
Time frame: From immediately after surgery to 30 days postoperatively
Incidence of acute myocardial injury
Time frame: From anesthesia induction to 24 hours after surgery
Incidence of acute kidney injury
Time frame: From anesthesia induction to 24 hours after surgery
Incidence of postoperative surgical site infection
Time frame: From immediately after surgery to 30 days postoperatively
Heart rate change immediately after intubation
Time frame: at anesthesia induction and immediately after intubation, assessed up to 10 seconds after intubation
Duration to postoperative first flatus time
Time frame: From the end of surgery to 7 days after surgery
Duration to postoperative first oral intake
Time frame: From the end of surgery to 7 days after surgery
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.
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
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
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
Time frame: from anesthesia induction to the end of surgery, assessed up to 5 minutes after surgery
The duration of intraoperative inadequate analgesia
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
Time frame: at 72 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Background: PubMed 39651972American Diabetes Association Professional Practice Committee. 16. Diabetes Care in the Hospital: Standards of Care in Diabetes-2025. Diabetes Care. 2025 Jan 1;48(1 Suppl 1):S321-S334. doi: 10.2337/dc25-S016.
- Background: PubMed 40744366You J, Chen X, Rong Y, Pan S, Liu T, Xie Y. Application value of different frailty assessment tools in older patients undergoing major abdominal surgery. Exp Gerontol. 2025 Oct 1;209:112852. doi: 10.1016/j.exger.2025.112852. Epub 2025 Jul 29.
- Background: PubMed 40758953Trocheris-Fumery O, Flet T, Scetbon C, Tarpin P, Meynier J, Badaoui R, De Broca B, Sabbagh C, Regimbeau JM, De Sousa P, Foulon A, Josse E, Dupont H, Bar S, Abou-Arab O. Early Use of Norepinephrine in High-risk Patients Undergoing Major Abdominal Surgery: A Randomized Controlled Trial. Anesthesiology. 2025 Nov 1;143(5):1160-1170. doi: 10.1097/ALN.0000000000005704. Epub 2025 Aug 4.
- Background: PubMed 41152837Zhang Y, Yan R, Kurexi A, Yuan T, Taati Z, Mijiti M, Li D, Wei F. The relationship between preoperative SPPB scores and 30-day postoperative pulmonary complications in elderly patients undergoing elective major abdominal surgery. BMC Surg. 2025 Oct 28;25(1):507. doi: 10.1186/s12893-025-03260-6.
- Background: PubMed 41136320Bieze M, McGinn R, Berrio-Valencia M, Talarico R, Martel G, McCluskey SA, McIsaac DI. Temporal trends in postoperative outcomes after major abdominal surgery: a population-based cohort study. Br J Anaesth. 2026 Jan;136(1):237-246. doi: 10.1016/j.bja.2025.08.030. Epub 2025 Oct 23.
- Background: PubMed 26985368Gameiro J, Neves JB, Rodrigues N, Bekerman C, Melo MJ, Pereira M, Teixeira C, Mendes I, Jorge S, Rosa R, Lopes JA. Acute kidney injury, long-term renal function and mortality in patients undergoing major abdominal surgery: a cohort analysis. Clin Kidney J. 2016 Apr;9(2):192-200. doi: 10.1093/ckj/sfv144. Epub 2016 Jan 18.
- Background: PubMed 24719758Teixeira C, Rosa R, Rodrigues N, Mendes I, Peixoto L, Dias S, Melo MJ, Pereira M, Bicha Castelo H, Lopes JA. Acute kidney injury after major abdominal surgery: a retrospective cohort analysis. Crit Care Res Pract. 2014;2014:132175. doi: 10.1155/2014/132175. Epub 2014 Feb 24.
- Background: PubMed 37788105Zhang W, Cheng Y, Zhang L, Wei Y, Xie H, Huang J. Association between emergence delirium and brain status parameters in children undergoing general anesthesia: A prospective observational study. Paediatr Anaesth. 2024 Feb;34(2):130-137. doi: 10.1111/pan.14779. Epub 2023 Oct 3.
- Background: PubMed 33269258Zhang JW, Lv ZG, Kong Y, Han CF, Wang BG. Wavelet and pain rating index for inhalation anesthesia: A randomized controlled trial. World J Clin Cases. 2020 Nov 6;8(21):5221-5234. doi: 10.12998/wjcc.v8.i21.5221.
- Background: PubMed 31517677Funcke S, Pinnschmidt HO, Wesseler S, Brinkmann C, Beyer B, Jazbutyte V, Behem CR, Trepte C, Nitzschke R. Guiding Opioid Administration by 3 Different Analgesia Nociception Monitoring Indices During General Anesthesia Alters Intraoperative Sufentanil Consumption and Stress Hormone Release: A Randomized Controlled Pilot Study. Anesth Analg. 2020 May;130(5):1264-1273. doi: 10.1213/ANE.0000000000004388.
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- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tianlong Wang, Doctor principal investigator
Xuanwu Hospital, Beijing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal brain monitoring guided anesthesia and Bispectral Index(BIS) monitoring guided anesthesia in people with Anesthesia, General and Major Abdominal Surgeries, run by Xuanwu Hospital, Beijing at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianlong Wang, Doctor (0086139 1052 5304, w_tl5595@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Composite Complication (time frame: From post-extubation to postoperative Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07713355, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.