Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients
ConditionOpioid Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorPeking University Shenzhen Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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）
Disqualifiers
Pregnancy or lactation period；
BMI ≥35 kg/m² or <18.5 kg/m²；
Anticipated difficult airway；
Previous diagnosis of hypertension；
Trial design
Design model
Parallel
Treatments tested in this trial
MGRNOX index-guided analgesia
DeviceAfter 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
DeviceAfter 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.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: MGRNOX index-guided analgesia groupExperimental treatment 1 intervention
Group B: Standard Clinical Care GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
opioids
Intraoperative remifentanil consumption, the dose unit is expressed as μg/kg/min.
Time frame
From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.Secondary outcomes
1
pain score
The numerical rating scale (NRS，11-point scale, with 0 indicating no pain and 10 indicating the most severe pain) after extubation was evaluated every 15 minutes
Time frame
One hour after extubation2
Incidence of unexpected events
severe hypotension：MAP\<50mmHg，severe hypertension：MAP\>120mmHg，tachycardia：HR\>120beats/min，bradycardia：HR\<40 beats/min，hypoxemia：SpO2≤92%，intraoperative awareness：Patients under general anesthesia showed a conscious state during the operation and could recall the surgery-related events that occurred during the operation postoperatively
Time frame
From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.3
incidence of complications
postoperative complications during PACU：Nausea and vomiting，agitation，delirium
Time frame
during PACU（at least 1 hour)4
the consumption of sedative drug
Intraoperative propofol consumption, the dose unit is expressed as mg/kg/h
Time frame
From the beginning of anesthesia induction until 5 minutes before the end of the surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov