Ignite Creation Date:
2024-05-06 @ 3:14 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566536
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2020-09-14
Brief Title:
NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery Under Propofol-remifentanil Anaesthesia
Status:
COMPLETED
Status Verified Date:
2023-04
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:
ROBOTNOL
Brief Summary:
Anesthesia quality and safety have improved over the past decades thanks to improved monitoring devices No nociception monitoring is currently part of the standard of care Usually hemodynamic parameters are used to evaluate nociception heart rate HR and mean arterial pressure MAP but none of them are specific However nociception evaluation is critical Indeed where excess of nociception can lead to arterial hypotension and respiratory depression insufficient nociception can lead to acute postoperative pain which is followed by persistent chronic pain in 10-50 of patients Different monitoring devices have been developed but none of them are still used in current practice Recently developed the nociception level NoL index MEDASENSE BIOMETRICS Ltd Ramat Gan Israel is an index of nociception based on a nonlinear algorithm combination of heart rate heart rate variability photoplethysmograph wave amplitude skin conductance skin conductance fluctuations and their time derivatives
Robotic surgeries have started to spread over the world 20 years ago claiming to be mini-invasive with less hemorrhage complications with better success based on the technical advantages of the robot allowing better access during anatomical challenges procedures Robotic surgery has been suggested to decrease pain during surgery and post-operatively because of the decreases abdominal wall constraints induced by the robotic arms compared to the surgeon arms
This observational prospective non-interventional monocentric study intend to evaluate the performance of the NoL index to discriminate protocol-defined nociceptive from non nociceptive stimuli during robotic surgery
All patients scheduled for a robotic surgery procedure will be orally informed about the study during the anesthesia consultation During the procedure the anesthesia procedure will be the same for all patients as part of the usual care in our department The NoL monitor will be added for the purpose of this study but the results will be hidden from all physicians All settings will be left the physician in charge At the end of the surgical procedure before transfer to the recovery room data for the monitor will be extracted on a dedicated universal serial bus USB key Files will be safely stored under RedCap before analysis
Robotic surgeries have started to spread over the world 20 years ago claiming to be mini-invasive with less hemorrhage complications with better success based on the technical advantages of the robot allowing better access during anatomical challenges procedures Robotic surgery has been suggested to decrease pain during surgery and post-operatively because of the decreases abdominal wall constraints induced by the robotic arms compared to the surgeon arms
This observational prospective non-interventional monocentric study intend to evaluate the performance of the NoL index to discriminate protocol-defined nociceptive from non nociceptive stimuli during robotic surgery
All patients scheduled for a robotic surgery procedure will be orally informed about the study during the anesthesia consultation During the procedure the anesthesia procedure will be the same for all patients as part of the usual care in our department The NoL monitor will be added for the purpose of this study but the results will be hidden from all physicians All settings will be left the physician in charge At the end of the surgical procedure before transfer to the recovery room data for the monitor will be extracted on a dedicated universal serial bus USB key Files will be safely stored under RedCap before analysis
Detailed Description:
Anesthesia quality and safety have improved over the past decades thanks to improved monitoring devices Excess of anesthetics could lead to arterial hypotension which has been shown to be associated with increased cardiovascular events On the other hand insufficient anesthetics could lead to awareness and memorization during general anesthesia GA Whereas almost all drugs currently used in the operating room OR have a validated monitoring tool no nociception monitoring is currently part of the standard of care Usually hemodynamic parameters are used to evaluate nociception heart rate HR and mean arterial pressure MAP but none of them are specific and several factors in the OR influence these parameters There is growing interest in the literature for nociception monitoring Indeed where excess of nociception can lead to arterial hypotension and respiratory depression insufficient nociception can lead to acute postoperative pain which is followed by persistent chronic pain in 10-50 of patients Opioids per se can also induce nausea and vomiting hyperalgesia for remifentanil
Different monitoring devices like the surgical pleth index pupillometry or the Analgesia Nociception Index have been developed based on several variables and algorithms but none of them are still used in current practice One of the major reason is that although they might had some effects on clinical parameters or drugs consumption none of them had any influence on patient outcome Recently developed the nociception level NoL index MEDASENSE BIOMETRICS Ltd Ramat Gan Israel is an index of nociception based on a nonlinear algorithm combination of heart rate heart rate variability photoplethysmograph wave amplitude skin conductance skin conductance fluctuations and their time derivatives One of the first study to report the ability of the NoL index to discriminate noxious from non-noxious stimuli with high sensitivity and specificity was performed in 2016 In that randomized trial continuous infusion of remifentanil target 2 versus 4 ngml enrolling 58 patients undergoing a large range of surgery the NoL index was superior than the hemodynamic parameters alone to characterize nociception In a study enrolling 72 patients randomized within 6 remifentanil concentration targets undergoing several surgical procedures by the same authors the NoL index was not affected by remifentanil doses whereas it had an dose-dependent hemodynamic effect on HR and MAP
Robotic surgeries have started to spread over the world 20 years ago claiming to be mini-invasive with less hemorrhage complications with better success based on the technical advantages of the robot allowing better access during anatomical challenges procedures Debates recently arise based on the procedures cost and the little or lack of evidence of mini-invasive procedures in patients with cancers Robotic surgery has been suggested to decrease pain during surgery and post-operatively in gynecologic thoracic and general procedures although results are controversial because of the decreases abdominal wall constraints induced by the robotic arms compared to the surgeon arms To our knowledge none of these studies evaluated pain based on a nociception monitoring device
This observational prospective non-interventional monocentric study intend to evaluate the performance of the NoL index to discriminate nociceptive from non nociceptive stimuli during robotic surgery
All patients scheduled for a robotic surgery procedure will be orally informed about the study during the anesthesia consultation During the procedure the anesthesia procedure will be the same for all patients as part of the usual care in our department Patients will be closely monitored by electrocardiogram intermittent blood pressure by arm cuff continuous pulse oximetry by finger probe neuromuscular monitoring by train-of-four TOF-Cuff bispectral index BIS monitoring using the BIS forehead 4-sensor The NoL monitor will be added for the purpose of this study but the results will be hidden The probe will be placed on the hand contralateral to the blood pressure arm cuff Anesthesia will be delivered by target-controlled infusion of remifentanil and propofol by two separate infusion pumps Once consciousness will be lost and a TOF calibration done neuromuscular blockade will be performed by rocuronium 06 mgkg All settings will be left the physician appreciation Different stimuli nociceptive and non-nociceptive are defined according to protocol such as intubation incision surgical haemostasia urinary track catheter and their time of arrival will be collected in a Case Report Form At the end of the surgical procedure before transfer to the recovery room data for the monitor will be extracted on a dedicated USB key Files will be safely stored under RedCap before analysis
Different monitoring devices like the surgical pleth index pupillometry or the Analgesia Nociception Index have been developed based on several variables and algorithms but none of them are still used in current practice One of the major reason is that although they might had some effects on clinical parameters or drugs consumption none of them had any influence on patient outcome Recently developed the nociception level NoL index MEDASENSE BIOMETRICS Ltd Ramat Gan Israel is an index of nociception based on a nonlinear algorithm combination of heart rate heart rate variability photoplethysmograph wave amplitude skin conductance skin conductance fluctuations and their time derivatives One of the first study to report the ability of the NoL index to discriminate noxious from non-noxious stimuli with high sensitivity and specificity was performed in 2016 In that randomized trial continuous infusion of remifentanil target 2 versus 4 ngml enrolling 58 patients undergoing a large range of surgery the NoL index was superior than the hemodynamic parameters alone to characterize nociception In a study enrolling 72 patients randomized within 6 remifentanil concentration targets undergoing several surgical procedures by the same authors the NoL index was not affected by remifentanil doses whereas it had an dose-dependent hemodynamic effect on HR and MAP
Robotic surgeries have started to spread over the world 20 years ago claiming to be mini-invasive with less hemorrhage complications with better success based on the technical advantages of the robot allowing better access during anatomical challenges procedures Debates recently arise based on the procedures cost and the little or lack of evidence of mini-invasive procedures in patients with cancers Robotic surgery has been suggested to decrease pain during surgery and post-operatively in gynecologic thoracic and general procedures although results are controversial because of the decreases abdominal wall constraints induced by the robotic arms compared to the surgeon arms To our knowledge none of these studies evaluated pain based on a nociception monitoring device
This observational prospective non-interventional monocentric study intend to evaluate the performance of the NoL index to discriminate nociceptive from non nociceptive stimuli during robotic surgery
All patients scheduled for a robotic surgery procedure will be orally informed about the study during the anesthesia consultation During the procedure the anesthesia procedure will be the same for all patients as part of the usual care in our department Patients will be closely monitored by electrocardiogram intermittent blood pressure by arm cuff continuous pulse oximetry by finger probe neuromuscular monitoring by train-of-four TOF-Cuff bispectral index BIS monitoring using the BIS forehead 4-sensor The NoL monitor will be added for the purpose of this study but the results will be hidden The probe will be placed on the hand contralateral to the blood pressure arm cuff Anesthesia will be delivered by target-controlled infusion of remifentanil and propofol by two separate infusion pumps Once consciousness will be lost and a TOF calibration done neuromuscular blockade will be performed by rocuronium 06 mgkg All settings will be left the physician appreciation Different stimuli nociceptive and non-nociceptive are defined according to protocol such as intubation incision surgical haemostasia urinary track catheter and their time of arrival will be collected in a Case Report Form At the end of the surgical procedure before transfer to the recovery room data for the monitor will be extracted on a dedicated USB key Files will be safely stored under RedCap before analysis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02744-53 | OTHER | IDRCB | None |