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AzTrials

Elective Laparoscopic CholecystectomyNORELACsNCT07810894

"Impact of NOciception Level (NOL) Index Intraoperative Guidance of REmifentanil Administration on Opioid Consumption and QoR in Ambulatory Patients Undergoing LAparoscopic Cholecystectomy."

A study testing Remifentanil titration based on Nociception Level Monitor and Remifetanil guided by vital parameters and clinical assessment in people with Elective Laparoscopic Cholecystectomy, run by Svendborg Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Laparoscopic cholecystectomy is a common surgical procedure which constitutes the standard treatment for symptomatic gallbladder disease. Elective procedures are performed as outpatient surgery due to the minimally invasive technique, fast recovery and low complication rates. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Elective Laparoscopic Cholecystectomy
What is being tested?
Remifentanil titration based on Nociception Level Monitor and Remifetanil guided by vital parameters and clinical assessment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteDenmark
Study dates
1 Dec 2023to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) class I-III
  • Patients aged 18 years +
  • Non-pregnant
  • Must read and understand Danish
  • Scheduled for ambulatory elective laparoscopic cholecystectomy

Who cannot join

  • Inability to give consent
  • Regular opioid use
  • Chronic kidney disease (eGFR<30)
  • Intolerance to opioids, and surgery converted to open procedure.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Odense University Hospital Svendborg

    Svendborg, Region Syddanmark, 5700

Other trials in Denmark

About this study

Official title: "Impact of NOciception Level (NOL) Index Intraoperative Guidance of REmifentanil Administration on Opioid Consumption and QoR in Ambulatory Patients Undergoing LAparoscopic Cholecystectomy. A Randomized Controlled Trial"

Background: Laparoscopic cholecystectomy is a common surgical procedure which constitutes the standard treatment for symptomatic gallbladder disease. Elective procedures are performed as outpatient surgery due to the minimally invasive technique, fast recovery and low complication rates. However, postoperative pain along with nausea and vomiting remains a common barrier to timely discharge from the post-anaesthesia care unit (1). The nociception level index (NOL) monitor provides a multiparametric measure of intraoperative nociception and may support individualized opioid titration (2-3). This single-center, prospective, single-blinded, randomised controlled trial investigated whether NOL-guided remifentanil administration reduces postoperative opioid consumption and improves early recovery compared with conventional clinician-guided analgesic management.

Methods: 120 adult patients scheduled for outpatient laparoscopic cholecystectomy were randomised to NOL-guided or conventional remifentanil titration during general anaesthesia. The NOL monitor quantifies nociception on a 0-100 scale. The intervention group received remifentanil titrated to maintain NOL values between 10-25, whereas remifentanil titration was adjusted according to standard clinical parameters in the control group. Postoperative recovery was assessed using the QoR40-questionnaire. Statistical analyses were performed using the median test, chi-square-test, and correlation analyses, with significance defined as p<0.05.

Being tested
Remifentanil titration based on Nociception Level Monitor, Remifetanil guided by vital parameters and clinical assessment
Keywords
Laparoscopic cholecystectomy, Nociceptive level monitoring, morphine, QoR40, recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remifentanil titration based on Nociception Level MonitorDevice

    Use of a nociception level monitor to guide remifentanil infusion during elective laparoscopic cholecystectomy

  • Remifetanil guided by vital parameters and clinical assessmentOther

    Patients were still connected to the nociception level monitor, but it was covered with af cloth and therefore did not influence the nurses administration of remifentanil. The nurses titrated the remifentanil according to standard clinical parameters.

Study groups in NCT07810894
Study groupRoleWhat they receive
Intervention groupActive comparatorGuidance of remifentanil infusion during elective laparoscopic cholecystectomy
Receives: Device: Remifentanil titration based on Nociception Level Monitor
Control GroupSham comparatorRemifentanil infusion guided by common parameters such as heart rate, blood pressure, airway pressure etc.
Receives: Other: Remifetanil guided by vital parameters and clinical assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphine consumption

    Postoperative morphine consumption in the postanasthesia care unit

    Measured: From arriving in the postanasthesia care unit to discharge from the unit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2026
  2. Study start1 Dec 2023
  3. Primary completion31 Aug 2024
  4. Study completion30 Sep 2024

Resources

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
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07810894
Sponsor's protocol ID
SvendborgH
Acronym
NORELACs
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patient characteristics and analysed results

Publications

  • Martini CH, Boon M, Broens SJ, Hekkelman EF, Oudhoff LA, Buddeke AW, Dahan A. Ability of the nociception level, a multiparameter composite of autonomic signals, to detect noxious stimuli during propofol-remifentanil anesthesia. Anesthesiology. 2015 Sep;123(3):524-34. doi: 10.1097/ALN.0000000000000757.

    PubMed 26154185

  • Renaud-Roy E, Stockle PA, Maximos S, Brulotte V, Sideris L, Dube P, Drolet P, Tanoubi I, Issa R, Verdonck O, Fortier LP, Richebe P. Correlation between incremental remifentanil doses and the Nociception Level (NOL) index response after intraoperative noxious stimuli. Can J Anaesth. 2019 Sep;66(9):1049-1061. doi: 10.1007/s12630-019-01372-1. Epub 2019 Apr 17.

    PubMed 30997633

  • Stockle PA, Julien M, Issa R, Decary E, Brulotte V, Drolet P, Henri M, Poirier M, Latulippe JF, Dorais M, Verdonck O, Fortier LP, Richebe P. Validation of the PMD100 and its NOL Index to detect nociception at different infusion regimen of remifentanil in patients under general anesthesia. Minerva Anestesiol. 2018 Oct;84(10):1160-1168. doi: 10.23736/S0375-9393.18.12720-9. Epub 2018 May 14.

    PubMed 29756750

  • Shahiri TS, Richebe P, Richard-Lalonde M, Gelinas C. Description of the validity of the Analgesia Nociception Index (ANI) and Nociception Level Index (NOL) for nociception assessment in anesthetized patients undergoing surgery: a systematized review. J Clin Monit Comput. 2022 Jun;36(3):623-635. doi: 10.1007/s10877-021-00772-3. Epub 2021 Nov 16.

    PubMed 34783941

  • Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.

    PubMed 30829658

  • Fuica R, Krochek C, Weissbrod R, Greenman D, Freundlich A, Gozal Y. Reduced postoperative pain in patients receiving nociception monitor guided analgesia during elective major abdominal surgery: a randomized, controlled trial. J Clin Monit Comput. 2023 Apr;37(2):481-491. doi: 10.1007/s10877-022-00906-1. Epub 2022 Aug 17.

    PubMed 35976578

  • Meijer 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 32950246

  • Ogata H, Matsuki Y, Okamoto T, Ueki R, Kariya N, Tatara T, Shigemi K, Hirose M. Intra-operative nociceptive responses and postoperative major complications after gastrointestinal surgery under general anaesthesia: A prospective cohort study. Eur J Anaesthesiol. 2021 Dec 1;38(12):1215-1222. doi: 10.1097/EJA.0000000000001505.

    PubMed 33831900

  • Ogata H, Nakamoto S, Miyawaki H, Ueki R, Kariya N, Tatara T, Hirose M. Association between intraoperative nociception and postoperative complications in patients undergoing laparoscopic gastrointestinal surgery. J Clin Monit Comput. 2020 Jun;34(3):575-581. doi: 10.1007/s10877-019-00347-3. Epub 2019 Jul 1.

    PubMed 31264131

  • Gornall BF, Myles PS, Smith CL, Burke JA, Leslie K, Pereira MJ, Bost JE, Kluivers KB, Nilsson UG, Tanaka Y, Forbes A. Measurement of quality of recovery using the QoR-40: a quantitative systematic review. Br J Anaesth. 2013 Aug;111(2):161-9. doi: 10.1093/bja/aet014. Epub 2013 Mar 6.

    PubMed 23471753

  • Kehlet H. Postoperative pain, analgesia, and recovery-bedfellows that cannot be ignored. Pain. 2018 Sep;159 Suppl 1:S11-S16. doi: 10.1097/j.pain.0000000000001243. No abstract available.

    PubMed 30113942

  • Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.

    PubMed 9175983

  • Jafra A, Mitra S. Pain relief after ambulatory surgery: Progress over the last decade. Saudi J Anaesth. 2018 Oct-Dec;12(4):618-625. doi: 10.4103/sja.SJA_232_18.

    PubMed 30429746

  • Xiong W, Li M, Wang M, Zhang S, Yang Q. The Safety of Laparoscopic Cholecystectomy in the Day Surgery Unit Comparing with That in the Inpatient Unit: A Systematic Review and Meta-Analysis. Biomed Res Int. 2020 Apr 28;2020:1924134. doi: 10.1155/2020/1924134. eCollection 2020.

    PubMed 32420324

  • Jensen K, Kehlet H, Lund CM. Post-operative recovery profile after laparoscopic cholecystectomy: a prospective, observational study of a multimodal anaesthetic regime. Acta Anaesthesiol Scand. 2007 Apr;51(4):464-71. doi: 10.1111/j.1399-6576.2006.01251.x.

    PubMed 17378786

Questions about this trial

What is this clinical trial studying?

A study testing Remifentanil titration based on Nociception Level Monitor and Remifetanil guided by vital parameters and clinical assessment in people with Elective Laparoscopic Cholecystectomy, run by Svendborg Hospital at 1 site in Denmark.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 Sep 2026. 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 Denmark. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphine consumption (time frame: From arriving in the postanasthesia care unit to discharge from the unit.). 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 NCT07810894, which also lists 16 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 14 Sep 2026.

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