The stress response to trauma and surgery.
J P Desborough
https://pubmed.ncbi.nlm.nih.gov/10927999Actively Recruiting
Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID07004686
Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients: A Randomized Controlled Trial
Led by Peking University Shenzhen Hospital · Updated on 2025-12-18
112
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of the MGRNOX index, derived from electroencephalogram (EEG) signals, to guide opioid pain management during general anesthesia in patients undergoing laparoscopic cholecystectomy. The study aims to see if this method can reduce opioid consumption, specifically remifentanil, compared to standard clinical care. Pain control during surgery is important to avoid complications related to too much or too little opioid use, and no current monitoring device is considered the definitive standard for guiding analgesic dosing. The trial compares two groups: one where remifentanil dosing is adjusted to keep the MGRNOX index between 30 and 50 during surgery while also monitoring blood pressure and heart rate, and a control group where dosing adjustments are based on blood pressure and heart rate alone. Both groups receive anesthesia induction followed by intraoperative remifentanil administration with adjustments as needed. The study uses a randomized, triple-blind design to evaluate the effectiveness of this EEG-based monitoring device. Participants will be monitored throughout the surgery, with opioid consumption measured from anesthesia induction until the final wound closure. Additional assessments include pain scores one hour after extubation, incidences of unexpected events and complications, and use of sedative and vasoactive drugs during surgery. This comprehensive evaluation will help determine if the MGRNOX-guided approach can optimize opioid use and improve surgical outcomes. The study runs until May 2026 and is sponsored by Peking University Shenzhen Hospital.
CONDITIONS
Brief Title
Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients
Who Can Participate
Age: 18Years - 64Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 65 years
- American Society of Anesthesiologists (ASA) class I-II
- Scheduled for elective laparoscopic cholecystectomy under general anesthesia without epidural anesthesia, local blocks, or infiltration
You will not qualify if you...
- Pregnancy or breastfeeding
- Body mass index (BMI) 35 kg/m² or higher, or less than 18.5 kg/m²
- Anticipated difficult airway
- Previous diagnosis of hypertension
- History of drug or alcohol abuse within the past 6 months
- Preoperative acute or chronic pain history or routine use of opioid or non-opioid analgesics
- Peripheral or central nervous system-related disorders
- Diagnosed psychiatric disorders or neuropsychiatric conditions affecting cognitive judgment, or history of psychotropic medication use
- Allergy or intolerance to anesthetic agents
- Baseline mean arterial pressure (MAP) less than 60 mmHg or greater than 120 mmHg; baseline heart rate (HR) less than 45 bpm or greater than 90 bpm
- History of severe underlying diseases such as untreated cardiovascular diseases, severe liver or kidney disorders, severe pulmonary diseases
- Implanted pacemaker, chronic arrhythmia, or preoperative use of certain heart medications such as anticholinergics, α2-adrenergic agonists, beta-1 adrenergic antagonists, or antiarrhythmic drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of surgery until final wound closure
Participants undergo laparoscopic cholecystectomy under general anesthesia. They receive either MGRNOX index-guided analgesia or standard clinical care to manage opioid dosing during surgery.
1 visit (in-person, during surgery)
Post-operative Follow-up
Duration - At least 1 hour after surgery
Participants are monitored for pain and complications during at least 1 hour in the post-anesthesia care unit (PACU) after surgery.
1 follow-up visit (in-person, post-surgery)
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Actively Recruiting
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Research Team
T
Tao Luo, MD,PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Are opioids indispensable for general anaesthesia?
Talmage D Egan
https://pubmed.ncbi.nlm.nih.gov/31104756Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis.
D Fletcher, V Martinez
https://pubmed.ncbi.nlm.nih.gov/24829420Monitoring the nociception-anti-nociception balance.
Matthias Gruenewald, Christoph Ilies
https://pubmed.ncbi.nlm.nih.gov/24012235Emerging drugs for the treatment of postsurgical pain.
Esra Kutlu Yalcin, Jorge Araujo-Duran, Alparslan Turan
https://pubmed.ncbi.nlm.nih.gov/34842026Surgical pleth index-guided remifentanil administration reduces remifentanil and propofol consumption and shortens recovery times in outpatient anaesthesia.
I Bergmann, A Göhner, T A Crozier...
https://pubmed.ncbi.nlm.nih.gov/23220856Intraoperative "Analgesia Nociception Index"-Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial.
Henry D Upton, Guy L Ludbrook, Andrew Wing...
https://pubmed.ncbi.nlm.nih.gov/28598927EEG-derived pain threshold index-guided versus standard care during propofol-remifentanil anesthesia: A randomized controlled trial.
Yu Jiang, Jian-Ming Ding, Xi-Xi Hao...
https://pubmed.ncbi.nlm.nih.gov/37593599Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial.
Fleur Meijer, Maarten Honing, Tessa Roor...
https://pubmed.ncbi.nlm.nih.gov/32950246Nociception monitors vs. standard practice for titration of opioid administration in general anesthesia: A meta-analysis of randomized controlled trials.
Dandan Ma, Jiahui Ma, Huayong Chen...
https://pubmed.ncbi.nlm.nih.gov/36091708