MGRNOX-guided general anesthesia to reduce opioid use during laparoscopic gallbladder surgery

Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients:A Randomized Controlled Trial

This trial will see if using the EEG-based MGRNOX index to guide anesthesia can reduce opioid use during laparoscopic cholecystectomy in adults.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Peking University Shenzhen Hospital (other)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07004686 on ClinicalTrials.gov

What this trial studies

Adults scheduled for elective laparoscopic cholecystectomy under general anesthesia are assigned to analgesia guided by the EEG-derived MGRNOX index or to standard clinical care. In the MGRNOX arm anesthesiologists titrate intraoperative opioid dosing based on the index, while the control arm uses routine signs such as heart rate and blood pressure. Primary outcome measures include intraoperative opioid consumption, with secondary outcomes covering postoperative pain, hemodynamic stability, opioid-related side effects, and recovery metrics. The trial is run at Peking University Shenzhen Hospital and excludes patients with chronic pain, recent opioid use, significant comorbidities, pregnancy, or extreme BMI or age.

Who should consider this trial

Good fit: Ideal candidates are adults 18–64 years old, ASA class I–II, scheduled for elective laparoscopic cholecystectomy without regional blocks, and without routine preoperative opioid use or major systemic disease.

Not a fit: Patients with chronic pain or routine opioid use, significant cardiovascular or neuropsychiatric conditions, pregnancy, extreme BMI, or who cannot attend the Shenzhen site are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, this approach could lower intraoperative opioid doses and reduce opioid-related side effects and delayed recovery.

How similar studies have performed: Other nociception monitors (e.g., SPI, ANI, qNOX) have shown reduced intraoperative opioid use and improved hemodynamic control in some trials, but MGRNOX itself has not yet been clinically validated.

Eligibility criteria

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.

Where this trial is running

Shenzhen, Guangdong

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Tao Luo, MD,PHD — Peking University Shenzhen Hospital
• Study coordinator: Tao Luo, MD,PHD

Conditions: Opioid Use