Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients
NCT ID: NCT07004686
Last Updated: 2025-12-18
Study Results
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Basic Information
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RECRUITING
NA
112 participants
INTERVENTIONAL
2025-06-28
2026-05-30
Brief Summary
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2. Although a variety of nociception monitoring devices have been developed to date, there is not a specific monitoring indicator that serves as the "gold standard" to objectively guide analgesic management in general anesthesia.
3. The MGRNOX index, which is derived from electroencephalogram (EEG), is used to reflect the correlation between noxious stimuli and opioid analgesics in a state of general anesthesia by converting and quantifying the EEG signals collected by the instrument. However, no studies have so far verified the effect of the MGRNOX index-guided analgesic management of general anesthesia on the consumption of opioids in patients.
4. This study aims to explore the effect of MGRNOX index-guided general anesthesia on opioid consumption in patients undergoing laparoscopic cholecystectomy and the primary hypothesis of our study is that using the MGRNOX index to guide intraoperative pain management during general anesthesia can significantly reduce the consumption of remifentanil during the surgery.
Detailed Description
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In recent years, various nociception monitoring devices (e.g., SPI, ANI, qNOX) have been developed to quantify intraoperative nociception, assisting anesthesiologists in optimizing analgesic administration to achieve precision and balanced anesthesia. Studies suggest that nociception-guided analgesia during general anesthesia surgery reduces opioid consumption, alleviates postoperative pain, and improves hemodynamic stability compared to traditional standardized management. However, due to the limitations of existing indices, no specific parameter has yet been established as a gold standard for objectively reflecting intraoperative nociception levels.
The MGRNOX index, a China-developed metric based on central nervous system monitoring, derives from processed and quantified electroencephalographic (EEG) signals under general anesthesia to reflect a patient's analgesic state. As clinical evidence for MGRNOX remains limited and its impact on intraoperative opioid usage remains unvalidated, the investigators designed this randomized controlled trial to investigate whether MGRNOX-guided general anesthesia reduces opioid consumption during laparoscopic cholecystectomies. Our primary hypothesis is that intraoperative MGRNOX-guided analgesia will significantly decrease remifentanil requirements.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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MGRNOX index-guided analgesia group
After anesthesia induction, the remifentanil plasma target concentration was adjusted intraoperatively to maintain the MGRNOX index within 30-50,but mean arterial pressure and heart rate were additionally monitored and considered.
MGRNOX index-guided analgesia
After anesthesia induction, the remifentanil plasma target concentration was adjusted intraoperatively to maintain the MGRNOX index between 30 and 50,but MAP and HR also were considered .In case the MGRNOX index was below 30 for more than 1 minute, remifentanil target-controlled infusion levels were lowered in steps of 0.5 ng/ml , whereas in case of a value greater than 50 for more than 1 minute, remifentanil target-controlled infusion levels were increased in steps of 0.5 ng/ml.
Standard Clinical Care Group
After anesthesia induction, the remifentanil plasma target concentration was adjusted intraoperatively based on mean arterial pressure and heart rate.
Standard Clinical Care
After anesthesia induction, if hypertension (MAP \> 100 mmHg) or tachycardia (heart rate \> 90 bpm) persists for more than 2 minutes, remifentanil target-controlled infusion levels were increased in steps of 0.5 ng/ml.If there is no response to remifentanil or the MAP and HR exceed a certain threshold, then urapidil or esmolol will be administered.For hypotension (50 mmHg \< MAP ≤ 60 mmHg) persisting for more than 2 minutes, remifentanil target-controlled infusion levels were lowered in steps of 0.5 ng/ml (lowest target plasma concentration that was allowed is 1 ng/ml), and 4μg of norepinephrine were given. If MAP ≤ 50 mmHg, remifentanil target-controlled infusion levels were lowered in steps of 0.5 ng/ml(lowest target plasma concentration that was allowed is 1 ng/ml), and 8μg of norepinephrine were given.
Interventions
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MGRNOX index-guided analgesia
After anesthesia induction, the remifentanil plasma target concentration was adjusted intraoperatively to maintain the MGRNOX index between 30 and 50,but MAP and HR also were considered .In case the MGRNOX index was below 30 for more than 1 minute, remifentanil target-controlled infusion levels were lowered in steps of 0.5 ng/ml , whereas in case of a value greater than 50 for more than 1 minute, remifentanil target-controlled infusion levels were increased in steps of 0.5 ng/ml.
Standard Clinical Care
After anesthesia induction, if hypertension (MAP \> 100 mmHg) or tachycardia (heart rate \> 90 bpm) persists for more than 2 minutes, remifentanil target-controlled infusion levels were increased in steps of 0.5 ng/ml.If there is no response to remifentanil or the MAP and HR exceed a certain threshold, then urapidil or esmolol will be administered.For hypotension (50 mmHg \< MAP ≤ 60 mmHg) persisting for more than 2 minutes, remifentanil target-controlled infusion levels were lowered in steps of 0.5 ng/ml (lowest target plasma concentration that was allowed is 1 ng/ml), and 4μg of norepinephrine were given. If MAP ≤ 50 mmHg, remifentanil target-controlled infusion levels were lowered in steps of 0.5 ng/ml(lowest target plasma concentration that was allowed is 1 ng/ml), and 8μg of norepinephrine were given.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) class I-II；
* Scheduled to undergo elective laparoscopic cholecystectomy undergeneral anesthesia （without epidural anesthesia, local blocks, or infiltration）
Exclusion Criteria
* BMI ≥35 kg/m² or \<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 (routine preoperative use of opioid or non-opioid analgesics), peripheral or central nervous system-related disorders；
* Definitively diagnosed psychiatric disorders or other neuropsychiatric conditions severely affecting cognitive judgment, history of psychotropic medication use；
* Allergy or intolerance to anesthetic agents；
* Baseline mean arterial pressure (MAP) \<60 mmHg or \>120 mmHg; baseline heart rate (HR) \<45 bpm or \>90 bpm (Baseline values defined as first measurement taken in the ward after admission)；
* History of severe underlying diseases (untreated or ongoing peripheral/central cardiovascular diseases, severe hepatic disorders with elevated bilirubin/INR or hypoalbuminemia, severe renal diseases with elevated creatinine, severe pulmonary diseases potentially causing acute respiratory failure or persistent dyspnea)；
* Implanted pacemaker, chronic arrhythmia, preoperative use of prescribed anticholinergics, α2-adrenergic agonists, beta-1 adrenergic antagonists, or antiarrhythmic medications.
18 Years
64 Years
ALL
No
Sponsors
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Peking University Shenzhen Hospital
OTHER
Responsible Party
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Principal Investigators
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Tao Luo, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
Peking University Shenzhen Hospital
Locations
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Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Tao Luo, MD,PHD
Role: primary
References
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Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
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Jiang Y, Ding JM, Hao XX, Fang PP, Liu XS. EEG-derived pain threshold index-guided versus standard care during propofol-remifentanil anesthesia: A randomized controlled trial. Heliyon. 2023 Aug 1;9(8):e18604. doi: 10.1016/j.heliyon.2023.e18604. eCollection 2023 Aug.
Meijer F, Honing M, Roor T, Toet S, Calis P, Olofsen E, Martini C, van Velzen M, Aarts L, Niesters M, Boon M, Dahan A. Reduced postoperative pain using Nociception Level-guided fentanyl dosing during sevoflurane anaesthesia: a randomised controlled trial. Br J Anaesth. 2020 Dec;125(6):1070-1078. doi: 10.1016/j.bja.2020.07.057. Epub 2020 Sep 17.
Ma D, Ma J, Chen H, Mu D, Kong H, Yu L. Nociception monitors vs. standard practice for titration of opioid administration in general anesthesia: A meta-analysis of randomized controlled trials. Front Med (Lausanne). 2022 Aug 25;9:963185. doi: 10.3389/fmed.2022.963185. eCollection 2022.
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Coeckelenbergh S, Sessler DI, Doria S, Patricio D, Jaubert L, Huybrechts I, Stefanidis C, Kapessidou P, Tuna T, Engelman E, Barvais L, Perrin L. Nociception level index-guided antinociception versus routine care during remifentanil-propofol anaesthesia for moderate-to-high risk cardiovascular surgery: A randomized trial. Eur J Anaesthesiol. 2023 Oct 1;40(10):790-793. doi: 10.1097/EJA.0000000000001892. Epub 2023 Jul 26. No abstract available.
Meijer FS, Niesters M, van Velzen M, Martini CH, Olofsen E, Edry R, Sessler DI, van Dorp ELA, Dahan A, Boon M. Does nociception monitor-guided anesthesia affect opioid consumption? A systematic review of randomized controlled trials. J Clin Monit Comput. 2020 Aug;34(4):629-641. doi: 10.1007/s10877-019-00362-4. Epub 2019 Jul 20.
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Jiang Z, Xiao J, Wang X, Luo T. The effect-site concentration of remifentanil blunting endotracheal intubation responses during anesthesia induction with etomidate: a dose-finding study. BMC Anesthesiol. 2023 Jun 28;23(1):225. doi: 10.1186/s12871-023-02165-2.
Bourgeois C, Oyaert L, Van de Velde M, Pogatzki-Zahn E, Freys SM, Sauter AR, Joshi GP, Dewinter G; PROSPECT working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after laparoscopic cholecystectomy: A systematic review and procedure-specific postoperative pain management (PROSPECT) recommendations. Eur J Anaesthesiol. 2024 Nov 1;41(11):841-855. doi: 10.1097/EJA.0000000000002047. Epub 2024 Sep 3.
Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.
Other Identifiers
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2025-024
Identifier Type: -
Identifier Source: org_study_id