Anesthesia Clinical Trial
— NOLopioidOfficial title:
Comparison of Opioid Consumption During Target Controlled Infusion (TCI) Guided by Nociception Level Index (NOL) or Standard Care Undergoing Intracranial Tumor Surgery, Randomized Controlled Study
Verified date | June 2023 |
Source | Turkish Society of Anesthesiology and Reanimation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | August 30, 2023 |
Est. primary completion date | October 2, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Intracranial 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Uludag University Medical Faculty | Bursa | Nilufer |
Lead Sponsor | Collaborator |
---|---|
Turkish Society of Anesthesiology and Reanimation | Uludag University |
Turkey,
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. — View Citation
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. — View Citation
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 administratio — View Citation
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.bj — View Citation
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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. — View Citation
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 — View Citation
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;12 — View Citation
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. — View Citation
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: 1 — View Citation
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. — View Citation
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 Pai — View Citation
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 noxi — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | comparison of administered remifentanil doses (mcg/kg/min) | 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. |
throughout the operation | |
Secondary | comparison of hemodynamic parameters | 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.
SAP, DAP, MAP, HR will be recorded before induction (T0), intubation (T1), head holder pinning (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. SAP, DAP, MAP 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. |
throughout the operation | |
Secondary | comparison of variability NOL index during severe noxious stimuli | NOL index changes before and after intubation, head holder pinning, 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. |
throughout the operation | |
Secondary | comparison of variability Heart rate during severe noxious stimuli | Heart rate changes before and after intubation, head holder pinning, 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. |
throughout the operation | |
Secondary | comparison of administered propofol dose (mg/kg/min) | 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. |
throughout the operation |
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