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

NCT07810894 | Completed

• 1 other identifier: SvendborgH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Elective Laparoscopic Cholecystectomy

Keywords

Laparoscopic cholecystectomy; Nociceptive level monitoring; morphine; QoR40; recovery

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Postoperative morphine consumption in the postanasthesia care unit

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

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Guidance of remifentanil infusion during elective laparoscopic cholecystectomy

Device: Remifentanil titration based on Nociception Level Monitor

Control Group

SHAM COMPARATOR

Remifentanil infusion guided by common parameters such as heart rate, blood pressure, airway pressure etc.

Other: Remifetanil guided by vital parameters and clinical assessment

Interventions

Remifetanil guided by vital parameters and clinical assessment OTHER

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.

Control Group

Remifentanil titration based on Nociception Level Monitor DEVICE

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Svendborg Hospital: lead
• Medtronic: collaborator

Study Sites (1)

Odense University Hospital Svendborg

Svendborg, Region Syddanmark, 5700, Denmark

Location

Related Publications (16)

• 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.

  PMID: 26154185 BACKGROUND

• 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.

  PMID: 30997633 BACKGROUND

• 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.

  PMID: 29756750 BACKGROUND

• 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.

  PMID: 34783941 BACKGROUND

• 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.

  PMID: 30829658 BACKGROUND

• 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.

  PMID: 35976578 BACKGROUND

• 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.

  PMID: 32950246 BACKGROUND

• 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.

  PMID: 33831900 BACKGROUND

• 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.

  PMID: 31264131 BACKGROUND

• 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.

  PMID: 23471753 BACKGROUND

• 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.

  PMID: 30113942 BACKGROUND

• 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.

  PMID: 9175983 BACKGROUND

• 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.

  PMID: 30429746 BACKGROUND

• 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.

  PMID: 32420324 BACKGROUND

• 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.

  PMID: 17378786 BACKGROUND

• Nazemroaya B, Keleidari B, Arabzadeh A, Honarmand A. Comparison of Intraperitoneal Versus Intravenous Dexamethasone on Postoperative Pain, Nausea, and Vomiting After Laparoscopic Cholecystectomy. Anesth Pain Med. 2022 Apr 30;12(2):e122203. doi: 10.5812/aapm-122203. eCollection 2022 Apr.

  PMID: 35991777 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Clinical Nurse Specialist who called the patients 2 weeks after surgery
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: December 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: September 2026
• Access Criteria: When the article is published

Locations

DK (1)