Opioid UseNCT07004686
Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients
A study testing MGRNOX index-guided analgesia and Standard Clinical Care in people with Opioid Use, run by Peking University Shenzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Opioid Use
- What is being tested?
- MGRNOX index-guided analgesia and Standard Clinical Care
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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）
Who cannot join
- 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；
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong
Tao Luo, MD,PHD, 13510820779, luotao_wh@yahoo.com
About this study
Official title: Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients:A Randomized Controlled Trial
- 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.
- 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.
- 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.
- 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.
Read the detailed description
Pain management is a critical component of perioperative anesthesia. Traditionally, anesthesiologists adjust analgesic dosages based on intraoperative heart rate or blood pressure, relying heavily on personal clinical experience. This approach often leads to over- or under-administration of analgesics. Currently, opioids remain the primary analgesics used in general anesthesia. Excessive opioid doses can result in postoperative hyperalgesia, delayed recovery, respiratory and circulatory depression, and increased hepatic/renal burden. Conversely, insufficient opioid doses may lead to inadequate analgesia, intraoperative hemodynamic instability, postoperative pain, and agitation.
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
- Opioid Use
- Being tested
- MGRNOX index-guided analgesia, Standard Clinical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGRNOX index-guided analgesiaDevice
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 CareDevice
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 group | Role | What they receive |
|---|---|---|
| MGRNOX index-guided analgesia group | Experimental | 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. Receives: Device: MGRNOX index-guided analgesia |
| Standard Clinical Care Group | Placebo comparator | After anesthesia induction, the remifentanil plasma target concentration was adjusted intraoperatively based on mean arterial pressure and heart rate. Receives: Device: Standard Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioids
Intraoperative remifentanil consumption, the dose unit is expressed as μg/kg/min.
Measured: From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.
Secondary outcomes (5)
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
Measured: One hour after extubation
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
Measured: From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.
incidence of complications
postoperative complications during PACU：Nausea and vomiting，agitation，delirium
Measured: during PACU（at least 1 hour)
the consumption of sedative drug
Intraoperative propofol consumption, the dose unit is expressed as mg/kg/h
Measured: From the beginning of anesthesia induction until 5 minutes before the end of the surgery.
the consumption of vasoactive drug
Intraoperative vasoactive drugs consumption，involved drug type and dosage
Measured: From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start28 Jun 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Luo, MD,PHD, Principal investigator, Peking University Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004686
- Sponsor's protocol ID
- 2025-024
- Status last verified
- May 2025
- First submitted
- 18 May 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
PubMed 10927999Egan TD. Are opioids indispensable for general anaesthesia? Br J Anaesth. 2019 Jun;122(6):e127-e135. doi: 10.1016/j.bja.2019.02.018. Epub 2019 Mar 28.
PubMed 31104756Fletcher 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.
PubMed 24829420Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
PubMed 24012235Kutlu Yalcin E, Araujo-Duran J, Turan A. Emerging drugs for the treatment of postsurgical pain. Expert Opin Emerg Drugs. 2021 Dec;26(4):371-384. doi: 10.1080/14728214.2021.2009799. Epub 2021 Nov 28.
PubMed 34842026Bergmann I, Gohner A, Crozier TA, Hesjedal B, Wiese CH, Popov AF, Bauer M, Hinz JM. Surgical pleth index-guided remifentanil administration reduces remifentanil and propofol consumption and shortens recovery times in outpatient anaesthesia. Br J Anaesth. 2013 Apr;110(4):622-8. doi: 10.1093/bja/aes426. Epub 2012 Dec 5.
PubMed 23220856Upton HD, Ludbrook GL, Wing A, Sleigh JW. Intraoperative "Analgesia Nociception Index"-Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial. Anesth Analg. 2017 Jul;125(1):81-90. doi: 10.1213/ANE.0000000000001984.
PubMed 28598927Jiang 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.
PubMed 37593599Meijer 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.
PubMed 32950246Ma 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.
PubMed 36091708Funcke S, Pinnschmidt HO, Brinkmann C, Wesseler S, Beyer B, Fischer M, Nitzschke R. Nociception level-guided opioid administration in radical retropubic prostatectomy: a randomised controlled trial. Br J Anaesth. 2021 Feb;126(2):516-524. doi: 10.1016/j.bja.2020.09.051. Epub 2020 Nov 20.
PubMed 33228979Renaud-Roy E, Morisson L, Brulotte V, Idrissi M, Godin N, Fortier LP, Verdonck O, Choiniere M, Richebe P. Effect of combined intraoperative use of the Nociception Level (NOL) and bispectral (BIS) indexes on desflurane administration. Anaesth Crit Care Pain Med. 2022 Jun;41(3):101081. doi: 10.1016/j.accpm.2022.101081. Epub 2022 Apr 25.
PubMed 35472586Coeckelenbergh 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.
PubMed 37497778Meijer 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.
PubMed 31327102Ledowski T. Objective monitoring of nociception: a review of current commercial solutions. Br J Anaesth. 2019 Aug;123(2):e312-e321. doi: 10.1016/j.bja.2019.03.024. Epub 2019 Apr 30.
PubMed 31047645
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of MGRNOX-Guided General Anesthesia on Opioid Consumption in Patients:A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07004686
- Acronym / sponsor ID
- 2025-024
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Study start
- 28 Jun 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 4 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
- 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
Pain management is a critical component of perioperative anesthesia. Traditionally, anesthesiologists adjust analgesic dosages based on intraoperative heart rate or blood pressure, relying heavily on personal clinical experience. This approach often leads to over- or under-administration of analgesics. Currently, opioids remain the primary analgesics used in general anesthesia. Excessive opioid doses can result in postoperative hyperalgesia, delayed recovery, respiratory and circulatory depression, and increased hepatic/renal burden. Conversely, insufficient opioid doses may lead to inadequate analgesia, intraoperative hemodynamic instability, postoperative pain, and agitation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGRNOX index-guided analgesia group | Experimental | Device: MGRNOX index-guided analgesiaAfter 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. |
| Standard Clinical Care Group | Placebo comparator | Device: Standard Clinical CareAfter anesthesia induction, the remifentanil plasma target concentration was adjusted intraoperatively based on mean arterial pressure and heart rate. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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）
Key exclusion criteria (11 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGRNOX index-guided analgesiaAfter 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 | MGRNOX index-guided analgesia group |
| Standard Clinical CareAfter 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. | Device | Standard Clinical Care Group |
Primary outcome
opioids
Time frame: 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.
5 secondary outcomes
pain score
Time frame: One hour after extubation
Incidence of unexpected events
Time frame: From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.
incidence of complications
Time frame: during PACU（at least 1 hour)
the consumption of sedative drug
Time frame: From the beginning of anesthesia induction until 5 minutes before the end of the surgery.
the consumption of vasoactive drug
Time frame: From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 10927999Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.
- Background: PubMed 31104756Egan TD. Are opioids indispensable for general anaesthesia? Br J Anaesth. 2019 Jun;122(6):e127-e135. doi: 10.1016/j.bja.2019.02.018. Epub 2019 Mar 28.
- Background: PubMed 24829420Fletcher 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.
- Background: PubMed 24012235Gruenewald M, Ilies C. Monitoring the nociception-anti-nociception balance. Best Pract Res Clin Anaesthesiol. 2013 Jun;27(2):235-47. doi: 10.1016/j.bpa.2013.06.007.
- Background: PubMed 34842026Kutlu Yalcin E, Araujo-Duran J, Turan A. Emerging drugs for the treatment of postsurgical pain. Expert Opin Emerg Drugs. 2021 Dec;26(4):371-384. doi: 10.1080/14728214.2021.2009799. Epub 2021 Nov 28.
- Background: PubMed 23220856Bergmann I, Gohner A, Crozier TA, Hesjedal B, Wiese CH, Popov AF, Bauer M, Hinz JM. Surgical pleth index-guided remifentanil administration reduces remifentanil and propofol consumption and shortens recovery times in outpatient anaesthesia. Br J Anaesth. 2013 Apr;110(4):622-8. doi: 10.1093/bja/aes426. Epub 2012 Dec 5.
- Background: PubMed 28598927Upton HD, Ludbrook GL, Wing A, Sleigh JW. Intraoperative "Analgesia Nociception Index"-Guided Fentanyl Administration During Sevoflurane Anesthesia in Lumbar Discectomy and Laminectomy: A Randomized Clinical Trial. Anesth Analg. 2017 Jul;125(1):81-90. doi: 10.1213/ANE.0000000000001984.
- Background: PubMed 37593599Jiang 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.
- Background: PubMed 32950246Meijer 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.
- Background: PubMed 36091708Ma 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.
- Background: PubMed 33228979Funcke S, Pinnschmidt HO, Brinkmann C, Wesseler S, Beyer B, Fischer M, Nitzschke R. Nociception level-guided opioid administration in radical retropubic prostatectomy: a randomised controlled trial. Br J Anaesth. 2021 Feb;126(2):516-524. doi: 10.1016/j.bja.2020.09.051. Epub 2020 Nov 20.
- Background: PubMed 35472586Renaud-Roy E, Morisson L, Brulotte V, Idrissi M, Godin N, Fortier LP, Verdonck O, Choiniere M, Richebe P. Effect of combined intraoperative use of the Nociception Level (NOL) and bispectral (BIS) indexes on desflurane administration. Anaesth Crit Care Pain Med. 2022 Jun;41(3):101081. doi: 10.1016/j.accpm.2022.101081. Epub 2022 Apr 25.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tao Luo, MD,PHD principal investigator
Peking University Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MGRNOX index-guided analgesia and Standard Clinical Care in people with Opioid Use, run by Peking University Shenzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Luo, MD,PHD (13510820779, luotao_wh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioids (time frame: From the beginning of anesthesia induction until surgical procedure end（time of final wound closure）,assessed during surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004686, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.