Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity
NCT ID: NCT04963036
Last Updated: 2022-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-07-28
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Entropy and NOL-Guided Goal Directed Anesthesia
Entropy and NOL-Guided Goal Directed Anesthesia
Entropy-guided Anesthesia (Propofol infusion in order to maintain Entropy between 45 and 55) and NOL-guided Analgesia (Remifentanil infusion in order to maintain NOL-Index between 10 and 25).
Standard of Care Group (Entropy and blinded NOL)
Standard of Care Group (Entropy and blinded NOL)
Entropy-guided Anesthesia (Propofol infusion in order to obtain Entropy between 45 and 55) and Remifentanil infusion at the discretion of the anesthetist in charge, based on current practice: patient vitals (Heart Rate, Blood Pressure, Respiratory Rate…), movements, spontaneous breathing, experience....
In this group, nociception monitor screen will be concealed and the NOL index will not be available for guidance of remifentanil dosing).
Interventions
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Entropy and NOL-Guided Goal Directed Anesthesia
Entropy-guided Anesthesia (Propofol infusion in order to maintain Entropy between 45 and 55) and NOL-guided Analgesia (Remifentanil infusion in order to maintain NOL-Index between 10 and 25).
Standard of Care Group (Entropy and blinded NOL)
Entropy-guided Anesthesia (Propofol infusion in order to obtain Entropy between 45 and 55) and Remifentanil infusion at the discretion of the anesthetist in charge, based on current practice: patient vitals (Heart Rate, Blood Pressure, Respiratory Rate…), movements, spontaneous breathing, experience....
In this group, nociception monitor screen will be concealed and the NOL index will not be available for guidance of remifentanil dosing).
Eligibility Criteria
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Inclusion Criteria
* Elective high-risk head and neck or maxillo-facial surgery
Exclusion Criteria
* Reduced ejection fraction below 40% and heart failure
* History of atrial Fibrillation, pulmonary embolism, recent cardioversion, recent cardiac ischemic episode, chronic hypotension, chronic kidney insufficiency (serum creatinine \> 1.5)
* Septic state
* Baseline heart-rate \< 50 or \> 90 bpm
* History of psychiatric disease or medication
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Saint Pierre
OTHER
Responsible Party
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Principal Investigators
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Panayota Kapessidou, MD,PhD
Role: STUDY_DIRECTOR
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Mehdi M'rini, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Locations
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CHU Saint-Pierre
Brussels, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Saugel B, Sessler DI. Perioperative Blood Pressure Management. Anesthesiology. 2021 Feb 1;134(2):250-261. doi: 10.1097/ALN.0000000000003610. No abstract available.
Sessler DI, Khanna AK. Perioperative myocardial injury and the contribution of hypotension. Intensive Care Med. 2018 Jun;44(6):811-822. doi: 10.1007/s00134-018-5224-7. Epub 2018 Jun 4.
Ruetzler K, Khanna AK, Sessler DI. Myocardial Injury After Noncardiac Surgery: Preoperative, Intraoperative, and Postoperative Aspects, Implications, and Directions. Anesth Analg. 2020 Jul;131(1):173-186. doi: 10.1213/ANE.0000000000004567.
Krzych LJ, Pluta MP, Putowski Z, Czok M. Investigating Association between Intraoperative Hypotension and Postoperative Neurocognitive Disorders in Non-Cardiac Surgery: A Comprehensive Review. J Clin Med. 2020 Sep 30;9(10):3183. doi: 10.3390/jcm9103183.
Feng X, Hu J, Hua F, Zhang J, Zhang L, Xu G. The correlation of intraoperative hypotension and postoperative cognitive impairment: a meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Aug 5;20(1):193. doi: 10.1186/s12871-020-01097-5.
Greaves D, Psaltis PJ, Davis DHJ, Ross TJ, Ghezzi ES, Lampit A, Smith AE, Keage HAD. Risk Factors for Delirium and Cognitive Decline Following Coronary Artery Bypass Grafting Surgery: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2020 Nov 17;9(22):e017275. doi: 10.1161/JAHA.120.017275. Epub 2020 Nov 7.
Belrose JC, Noppens RR. Anesthesiology and cognitive impairment: a narrative review of current clinical literature. BMC Anesthesiol. 2019 Dec 27;19(1):241. doi: 10.1186/s12871-019-0903-7.
Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
Evered LA, Silbert BS. Postoperative Cognitive Dysfunction and Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):496-505. doi: 10.1213/ANE.0000000000003514.
Ledowski T. Monitoring nociception-getting 'there yet' might be easier with a road map. Br J Anaesth. 2017 Oct 1;119(4):716-717. doi: 10.1093/bja/aex277. No abstract available.
Ledowski 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.
De Jonckheere J, Bonhomme V, Jeanne M, Boselli E, Gruenewald M, Logier R, Richebe P. Physiological Signal Processing for Individualized Anti-nociception Management During General Anesthesia: a Review. Yearb Med Inform. 2015 Aug 13;10(1):95-101. doi: 10.15265/IY-2015-004.
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.
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.
Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
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.
Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27.
Danielson M, Wiklund A, Granath F, Blennow K, Mkrtchian S, Nellgard B, Oras J, Jonsson Fagerlund M, Granstrom A, Schening A, Rasmussen LS, Erlandsson Harris H, Zetterberg H, Ricksten SE, Eriksson LI. Neuroinflammatory markers associate with cognitive decline after major surgery: Findings of an explorative study. Ann Neurol. 2020 Mar;87(3):370-382. doi: 10.1002/ana.25678. Epub 2020 Jan 25.
Other Identifiers
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B0762021210506
Identifier Type: -
Identifier Source: org_study_id
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