Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity

NCT04963036 | Unknown

• 1 other identifier: B0762021210506
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high risk patients. The investigator will also investigate the effects of guided anesthesia on postoperative Myocardial Injury in Non-cardiac Surgery (MINS) and Postoperative cognitive dysfunction (POCD), amongst other frequent postoperative complications, in this population.

Conditions

Head and Neck Surgery; Maxillofacial Surgery

Keywords

Nociception; Entropy; Analgesia; Goal Directed Anesthesia Therapy (GDAT); Remifentanil; Intraoperative Hypotension; Myocardial Injury in Non-Cardiac Surgery (MINS); Postoperative Cognitive Dysfunction (POCD)

Outcome Measures

Primary Outcomes (4)

• Occurrence of intraoperative hypotension

  Occurrence of intraoperative hypotension is defined by at least 1 minute under the hypotension thresholds. Moderate and Severe Hypotension are respectively defined as a Mean Blood Pressure \<65 mmHg or \<55 mmHg and \<75 or \<65 mmHg for patient with history of chronic hypertension

  during surgery

• Total Vasopressor Dose

  Total Vasopressor Dose used throughout the intervention to maintain Arterial Pressure within a pre-defined individualized ranges (≥ 65 mmHg or ≥75 mmHg for patient with history of chronic hypertension, and ≤ 100 mmHg)

  during surgery

• Number of interventions to cure intraoperative hypotension

  Number of vasopressor boli or vasopressor infusion dose adjustments

  during surgery

• Total Time under hypotension thresholds

  Hypotension Thresholds ( \<65 mmHg or \< 75mmHg for patient with history of chronic hypertension)

  during surgery

Secondary Outcomes (10)

• Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T)

  up to 48 hours after surgery

• Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate)

  up to 48 hours after surgery

• Postoperative Cognitive Decline (POCD)

  up to 6 months after surgery

• PostOperative Delirium (PO Delirium)

  up to 6 months after surgery

• Dosage of Stress Hormones

  up to 4 hours after surgery

Study Arms (2)

Entropy and NOL-Guided Goal Directed Anesthesia

EXPERIMENTAL

Other: Entropy and NOL-Guided Goal Directed Anesthesia

Standard of Care Group (Entropy and blinded NOL)

ACTIVE COMPARATOR

Other: Standard of Care Group (Entropy and blinded NOL)

Interventions

Entropy and NOL-Guided Goal Directed Anesthesia OTHER

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).

Entropy and NOL-Guided Goal Directed Anesthesia

Standard of Care Group (Entropy and blinded NOL) OTHER

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).

Standard of Care Group (Entropy and blinded NOL)

Eligibility Criteria

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

You may qualify if:

• Age ≥18
• Elective high-risk head and neck or maxillo-facial surgery

You may not qualify if:

• Patient refusal
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Related Publications (19)

• Saugel B, Sessler DI. Perioperative Blood Pressure Management. Anesthesiology. 2021 Feb 1;134(2):250-261. doi: 10.1097/ALN.0000000000003610. No abstract available.

  PMID: 33206118 BACKGROUND

• 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.

  PMID: 29868971 BACKGROUND

• 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.

  PMID: 31880630 BACKGROUND

• 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.

  PMID: 33008109 BACKGROUND

• 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.

  PMID: 32758153 BACKGROUND

• 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.

  PMID: 33164631 BACKGROUND

• 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.

  PMID: 31881996 BACKGROUND

• 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.

  PMID: 23835589 BACKGROUND

• Evered LA, Silbert BS. Postoperative Cognitive Dysfunction and Noncardiac Surgery. Anesth Analg. 2018 Aug;127(2):496-505. doi: 10.1213/ANE.0000000000003514.

  PMID: 29889707 BACKGROUND

• 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.

  PMID: 29121306 BACKGROUND

• 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.

  PMID: 31047645 BACKGROUND

• 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.

  PMID: 26293855 BACKGROUND

• 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

• 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

• 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.

  PMID: 28973220 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

• 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.

  PMID: 27792044 BACKGROUND

• 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.

  PMID: 30916004 BACKGROUND

• 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.

  PMID: 31930549 BACKGROUND

MeSH Terms

Conditions

Agnosia; Postoperative Cognitive Complications

Interventions

Entropy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thermodynamics; Physical Phenomena

Study Officials

• Panayota Kapessidou, MD,PhD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  STUDY DIRECTOR

• Mehdi M'rini, MD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panayota Kapessidou, MD,PhD

CONTACT

+32.2.535; pkapessi@ulb.ac.be

Mehdi M'rini, MD

CONTACT

+32.2.535; m.mrini@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 15, 2021
• Study Start: July 28, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 15, 2022

Record last verified: 2021-07

Locations

BE (1)