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

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.

Conditions

• Opioid Use

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

• Peking University Shenzhen Hospital

  lead OTHER

Principal Investigators

• Tao Luo, MD,PHD · Peking University Shenzhen Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-28

Primary Completion

2026-05-30

Completion

2026-05-30

Countries

• China

Study Locations