Trial Title:
Comparison of Opioid Consumption During TCI Guided by NOL Index or Standard Care Undergoing Intracranial Tumor Surgery
NCT ID:
NCT05732896
Condition:
Target Controlled Infusion
Intracranial Neoplasm
Opioid
Nociceptive Pain
Anesthesia
Conditions: Official terms:
Brain Neoplasms
Nociceptive Pain
Conditions: Keywords:
target controlled infusion
intraoperative nociception monitoring
Nociception Level index
neuroanesthesia
intracranial tumor surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Nociception Leve Indeks
Description:
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.
Arm group label:
study group
Summary:
In this prospective, randomized controlled study, we hypothesized that nociception level
index monitoring reduced opioid administration during surgery. The secondary goals are to
compare the total dose hypnotic drugs, as well as hemodynamic parameters, and to
investigate the relationship between changes in the NOL index and HR change following
severe noxious stimuli during effect site TCI of propofol and remifentanil in patients
undergoing intracranial tumor surgery who are monitored using either standard monitors or
the NOL monitor additionally.
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 (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) .
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- İntracranial mass surgery
- Craniotomy
- ASA II-II
- elective surgery
Exclusion Criteria:
- pregnant or suspected of pregnancy
- receive antiarrhythmic therapy
- autonomic nervous system disease
- ASA IV
- emergency surgery
- patients with difficult airway features
- patients receiving chronic pain treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Uludag University Medical Faculty
Address:
City:
Bursa
Zip:
16140
Country:
Turkey
Start date:
September 2, 2020
Completion date:
August 30, 2023
Lead sponsor:
Agency:
Turkish Society of Anesthesiology and Reanimation
Agency class:
Other
Collaborator:
Agency:
Uludag University
Agency class:
Other
Source:
Turkish Society of Anesthesiology and Reanimation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05732896
