NOLopioid: Comparison of Opioid Consumption During TCI Guided by NOL Index or Standard Care Undergoing Intracranial Tumor Surgery
Study Details
Study Description
Brief Summary
The aim of this prospective, randomized controlled study was to compare to opioid consumption and hemodynamic parameters during Target Controlled Infusion (TCI) guided by Nociception Level (NOL) index or standard care in patients undergoing intracranial tumor surgery. The secondary goal is to examine the variability of Heart Rate (HR) and NOL index after severe noxious stimuli (i.e. intubation, placement of pin holder, skin incision, craniotomy).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The study will be conducted on 50 patients aged between 18-75 years, with the American Society of Anesthesiologists (ASA) classification II-III, who would undergo intracranial tumor surgery after ethics committee approval (08/09/2020, 2020-15/15) and written consent from the patients. Standard monitoring (invasive arterial monitoring, 5-lead ECG, peripheral oxygen saturation-SpO2) and Bispectral Index Score (BIS) monitoring will be performed in the standard care group (SC; n=25), and NOL index monitoring will be performed in addition to standard monitors in the NOL guided group (NOL-G; n=25).
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 (SAB, DAP, MAP), Heart Rate (HR), SpO2, BIS scores will be recorded before induction, intubation, placement of pin holder, 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, placement of pin holder, 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) .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: control group standard care group |
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| Active Comparator: study group NOL guided group |
Device: Nociception Leve İndeks
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.
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Outcome Measures
Primary Outcome Measures
- comparison of administered remifentanil doses (mcg/kg/min) [throughout the operation]
This data will be obtained from the TCI device. Demographic data such as the patient's gender, age, weight, etc. are entered into the TCI device. The TCI device displays the total duration of the operation as hour and the total amount of drug used as microgram. To control for patient weight and duration of surgery, we report the anesthesia drug doses as dose/kg/min of anesthesia time.The remifentanil administration dose is indicated in mcg/kg/min. "kg" is patient's actual body weight. "min" is operating time in minutes.
- comparison of administered propofol dose (mg/kg/min) [throughout the operation]
This data will be obtained from the TCI device. Demographic data such as the patient's gender, age, weight, etc. are entered into the TCI device. The TCI device displays the total duration of the operation as hour and the total amount of drug used as milligram. To control for patient weight and duration of surgery, we report the anesthesia drug doses as dose/kg/min of anesthesia time. The propofol administration dose is indicated in mg/kg/min. "kg" is patient's actual body weight. "min" is operating time in minutes.
- comparison of hemodynamic parameters [throughout the operation]
Standard (invasive arterial monitoring, 5-lead ECG, peripheral oxygen saturation-SpO2) and BIS monitoring will be performed in the SC group, and NOL index monitoring will be performed in addition to standart monitors in the NOL-G group. SAB, DAP, MAP, HR will be recorded before induction (T0), intubation (T1), placement of pin holder (T2), skin incision (T3), muscle and periosteal dissection (T4), craniotomy (T5), dural incision (T6), tumor excision (T7), dural suturation (T8), muscle and periosteum suturation(T9), skin suturation (T10), and interruption of infusions (T11). Hemodynamic parameters and BIS score are recorded on the anesthesia device monitor. SAB, DAB, OAB are defined as mmhg. HR is defined as beat per minute BIS score and NOL index give an index between 0-100. NOL index device saves data itself and this data can be exported via flash memory.
- comparison of variability NOL index during severe noxious stimuli [throughout the operation]
NOL index changes before and after intubation, placement of pin holder, skin incision, and craniotomy, which were determined and compared as severe noxious stimuli. The NOL index device records the heart rate and the NOL index every 5 seconds.
- comparison of variability Heart rate during severe noxious stimuli [throughout the operation]
Heart rate changes before and after intubation, placement of pin holder, skin incision, and craniotomy, which were determined and compared as severe noxious stimuli. The NOL index device records the heart rate and the NOL index every 5 seconds.
Eligibility Criteria
Criteria
Inclusion Criteria:
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İntracranial mass surgery
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Craniotomy
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ASA II-II
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elective surgery
Exclusion Criteria:
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pregnant or suspected of pregnancy
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receive antiarrhythmic therapy
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autonomic nervous system disease
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ASA IV
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emergency surgery
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patients with difficult airway features
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patients receiving chronic pain treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uludag University Medical Faculty | Bursa | Nilufer | Turkey | 16140 |
Sponsors and Collaborators
- Turkish Society of Anesthesiology and Reanimation
- Uludag University
Investigators
- Study Director: Hulya Bilgin, Bursa Uludağ University Faculty of Medicine Department of Anesthesiology and Reanimation
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- NOLguidedopioid