Comparison of Opioid Consumption During TCI Guided by NOL Index or Standard Care Undergoing Intracranial Tumor Surgery
NCT ID: NCT05732896
Last Updated: 2023-06-22
Study Results
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Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-09-02
2023-08-30
Brief Summary
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Detailed Description
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During TCI, propofol (Schnider) effect-site concentration (Ce) will be titrated to BIS score between 40-60 and remifentanil (Minto) Ce to standard hemodynamic parameters in the SC group and NOL index between 10-25 in the NOL-G group.
In all patients, Systolic, Diastolic and Mean Arterial Pressure (SAP, DAP, MAP), Heart Rate (HR), SpO2, BIS scores will be recorded before induction, intubation, head holder pinning, skin incision, muscle and periosteal dissection, craniotomy, dural incision, tumor excision, dural suturation, muscle and periosteum suturation, skin suturation, and interruption of infusions. In addition, NOL index in the NOL-G group patients will be recorded in all that time.
Hemodynamic parameters, to be administered propofol and remifentanil doses will be compared in two groups. NOL index changes before and after intubation, head holder pinning, skin incision and craniotomy, which are determined as severe noxious stimuli, will be compared with changes in HR.
Traditionally, the hemodynamic reactivity such as increased HR and blood pressure (BP), and/or nocifensive movements in the absence of paralytic agents are clinically considered for the assessment of nociception. The response to nociceptive stimuli is monitored as an increase in sympathetic or a decrease in parasympathetic tone (Guignard, 2006). The sympathetic response generates physiological changes such as increased HR, increased peripheral vasoconstriction, pupillary dilation, and changes in galvanic skin conductance (Guignard, 2006). As the understanding of nociception has grown in the past two decades, the industry has developed various nociception detecting devices based on some of the mentioned parameters.The only multi-parameter device is the Nociception Level (NOL) index (Ledowski, 2019). Evidence suggests the multi-parameter approach may be superior to the single-parameter approach for the assessment of nociceptive pain induced by tonic heat stimuli among healthy volunteers (Treister et al., 2012)
The PMD-200 system (NOL device) consists of a display and computing unit, a reusable non-invasive finger probe and a single-use sensor.The proprietary signal acquisition sensor platform (the combination of the finger probe and the single-use sensor) acquires physiological signals. Using advanced algorithms, the system processes and analyses multiple nociception related physiological parameters and their various derivatives, which correspond with the sympathetic nervous system's response to noxious stimuli. The finger probe and single-use sensor continuously acquire four physiological signals through the following four sensors; photoplethysmograph (PPG), galvanic Skin Response (GSR), peripheral Temperature (Temp), accelerometer (ACC). From these four signals the NOL algorithm extracts and analyses nociception-related physiological parameters and derivatives: pulse rate, pulse rate variability, pulse wave amplitude, skin conductance level, peripheral temperature, movement, and their various derivatives. Then a patient's specific nociception signature is established and continuously monitored. Peripheral temperature and movement serve as guardrails supporting algorithm validity and do not contribute directly to the algorithm calculation.
In 2013, Ben-Israel et al., published the first study on the multiparametric Nociception Level index (NOL). The few validation studies to date allowed the preliminary conclusion that the NOL index presented as an accurate means to measure the level of nociception during general anesthesia (Edry et al., 2016) . On the other hand, there are studies showing that the NOL index monitor does not reduce opioid consumption, or even though it does, there is no significant difference (Espitalier et al., 2021; F. Meijer et al., 2020; Niebhagen et al., 2022; Renaud-Roy et al., 2022) In addition, many studies in the literature indicate that NOL index monitoring is a reliable monitor in the evaluation of nociception or in distinguishing noxius stimuli (Renaud-Roy et al., 2019) (Treister et al., 2012) (Edry et al., 2016) (Martini et al., 2015) (Bollag et al., 2018) .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
QUADRUPLE
Study Groups
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control group
standard care group
No interventions assigned to this group
study group
NOL guided group
Nociception Leve Indeks
During TIVA-TCI, propofol (Schnider) effect site concentration (Ce) was titrated to BIS score between 40-60 and remifentanil (Minto) Ce to standard hemodynamic parameters in the control group and NOL index value between 10-25 in the study group.
Interventions
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Nociception Leve Indeks
During TIVA-TCI, propofol (Schnider) effect site concentration (Ce) was titrated to BIS score between 40-60 and remifentanil (Minto) Ce to standard hemodynamic parameters in the control group and NOL index value between 10-25 in the study group.
Eligibility Criteria
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Inclusion Criteria
* Craniotomy
* ASA II-II
* elective surgery
Exclusion Criteria
* receive antiarrhythmic therapy
* autonomic nervous system disease
* ASA IV
* emergency surgery
* patients with difficult airway features
* patients receiving chronic pain treatment
18 Years
65 Years
ALL
Yes
Sponsors
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Uludag University
OTHER
Turkish Society of Anesthesiology and Reanimation
OTHER
Responsible Party
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Principal Investigators
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Hulya Bilgin
Role: STUDY_DIRECTOR
Bursa Uludağ University Faculty of Medicine Department of Anesthesiology and Reanimation
Locations
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Uludag University Medical Faculty
Bursa, Nilufer, Turkey (Türkiye)
Countries
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References
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Guignard B. Monitoring analgesia. Best Pract Res Clin Anaesthesiol. 2006 Mar;20(1):161-80. doi: 10.1016/j.bpa.2005.09.002.
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.
Ben-Israel N, Kliger M, Zuckerman G, Katz Y, Edry R. Monitoring the nociception level: a multi-parameter approach. J Clin Monit Comput. 2013 Dec;27(6):659-68. doi: 10.1007/s10877-013-9487-9. Epub 2013 Jul 9.
Edry R, Recea V, Dikust Y, Sessler DI. Preliminary Intraoperative Validation of the Nociception Level Index: A Noninvasive Nociception Monitor. Anesthesiology. 2016 Jul;125(1):193-203. doi: 10.1097/ALN.0000000000001130.
Funcke 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.
Ma 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.
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.
Espitalier F, Idrissi M, Fortier A, Belanger ME, Carrara L, Dakhlallah S, Rivard C, Brulotte V, Zaphiratos V, Loubert C, Godin N, Fortier LP, Verdonck O, Richebe P. "Impact of Nociception Level (NOL) index intraoperative guidance of fentanyl administration on opioid consumption, postoperative pain scores and recovery in patients undergoing gynecological laparoscopic surgery. A randomized controlled trial". J Clin Anesth. 2021 Dec;75:110497. doi: 10.1016/j.jclinane.2021.110497. Epub 2021 Sep 28.
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.
Niebhagen F, Golde C, Koch T, Hubler M. [Does NoL monitoring affect opioid consumption during da Vinci prostatectomy?]. Anaesthesiologie. 2022 Sep;71(9):683-688. doi: 10.1007/s00101-022-01126-7. Epub 2022 May 25. German.
Renaud-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.
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.
Treister R, Kliger M, Zuckerman G, Aryeh IG, Eisenberg E. Differentiating between heat pain intensities: the combined effect of multiple autonomic parameters. Pain. 2012 Sep;153(9):1807-1814. doi: 10.1016/j.pain.2012.04.008. Epub 2012 May 29.
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.
Other Identifiers
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NOLguidedopioid
Identifier Type: -
Identifier Source: org_study_id
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