Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients

NCT07004686 · tracked via the Priya Life Science China tracker

Sponsor

Peking University Shenzhen Hospital

Phase

Not applicable

Started

2025-06-28

Last updated

2025-12-18

Condition(s) studied

Opioid Use

Investigational drug(s) / intervention(s)

MGRNOX index-guided analgesiaStandard Clinical Care

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.

Study summary

1. Pain management is a crucial part of general anesthesia surgery. Nociception monitoring can help anesthesiologists better titrate the use of intraoperative analgesic drugs, especially the opioid.
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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

64 Years

Healthy volunteers

Inclusion Criteria: * Age ≥18 years old and \< 65 years old； * 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: * Pregnancy or lactation period； * 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.

Primary outcome measure(s)

opioids — From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.
Intraoperative remifentanil consumption, the dose unit is expressed as μg/kg/min.

Trial sites (1)

Facility	City	Region	Status
Peking University Shenzhen Hospital	Shenzhen	Guangdong	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07004686 on ClinicalTrials.gov ↗ ← All trials in China