Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03324269
Status:
COMPLETED
Last Update Posted:
2021-02-09
First Post:
2017-10-16
Brief Title:
Evaluating the Predictive Value of the Nociception Level Index NOL
Sponsor:
Université Libre de Bruxelles
Organization:
Université Libre de Bruxelles
Study Overview
Official Title:
Evaluating the Predictive Value of the Nociception Level Index NOL a Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Opioids remain the cornerstone for perioperative analgesia albeit frequently associated with side effects Most of these side-effects are dose-dependent
Thus intra-operative monitors are necessary to measure the balance between Nociception and Anti-Nociception NAN balance by an adequate opioid administration
Recently the NOL monitor was releasedThe NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables specifically heart rate HR heart rate variability at the 015- to 04-Hz band power photoplethysmograph wave amplitude PPGA skin conductance level number of skin conductance fluctuations and their time derivatives The NoL index estimates the nociceptiveantinociceptive state from these component measures using random forest regression
In our department a combination of TCI propofol Schnider model and remifentanil Minto model is used to for most of the anaesthetic procedures including cardiac anaesthesia Remifentanil is titrated to prevent an increase in blood pressure and hearth rhythm at noxious stimuli such as surgical incision and adapted following hemodynamic trend during surgery
The hypothesis of this study is to develop a calibration test using the NOL index variation to define the individual most appropriate NAN balance using remifentanil TCI before the start of surgery and before a very strong noxious surgical stimulus such as surgical incision in non-cardiac and cardiac surgery
Before the start of surgery the investigators want to titrate in each patient the remifentanil Ce required to abolish the NOL index response to a calibrated noxious tetanic stimulus Tetanus 60 mamp 100 Hz 30 seconds Thus this individual remifentanil Ce will be the remifentanil level programmed before surgical incision NOL and hemodynamic responses will be recorded during the entire duration of surgery
Study protocol amendment validation of the calibration study Data from the calibration phase will be used to derive a formula to predict individualised anti-nociception for incision
Thus intra-operative monitors are necessary to measure the balance between Nociception and Anti-Nociception NAN balance by an adequate opioid administration
Recently the NOL monitor was releasedThe NoL index ranges from 0 to 100 and is based on a nonlinear combination of nociception-related physiologic variables specifically heart rate HR heart rate variability at the 015- to 04-Hz band power photoplethysmograph wave amplitude PPGA skin conductance level number of skin conductance fluctuations and their time derivatives The NoL index estimates the nociceptiveantinociceptive state from these component measures using random forest regression
In our department a combination of TCI propofol Schnider model and remifentanil Minto model is used to for most of the anaesthetic procedures including cardiac anaesthesia Remifentanil is titrated to prevent an increase in blood pressure and hearth rhythm at noxious stimuli such as surgical incision and adapted following hemodynamic trend during surgery
The hypothesis of this study is to develop a calibration test using the NOL index variation to define the individual most appropriate NAN balance using remifentanil TCI before the start of surgery and before a very strong noxious surgical stimulus such as surgical incision in non-cardiac and cardiac surgery
Before the start of surgery the investigators want to titrate in each patient the remifentanil Ce required to abolish the NOL index response to a calibrated noxious tetanic stimulus Tetanus 60 mamp 100 Hz 30 seconds Thus this individual remifentanil Ce will be the remifentanil level programmed before surgical incision NOL and hemodynamic responses will be recorded during the entire duration of surgery
Study protocol amendment validation of the calibration study Data from the calibration phase will be used to derive a formula to predict individualised anti-nociception for incision
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None