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NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery (ROBOTNOL)

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ClinicalTrials.gov Identifier: NCT04566536
Recruitment Status : Suspended ("Owing to the Covid-19 epidemics and in the application of guidelines, inclusions have been suspended in the ROBOTNOL research on March 26th 2021 for an undetermined period of time.")
First Posted : September 28, 2020
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease
Anesthesia Pain Management

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NoL Monitor Performances of Nociceptive and Non-nociceptive Stimuli Discrimination During Robotic Surgery Under Propofol-remifentanil Anaesthesia
Actual Study Start Date : October 7, 2020
Estimated Primary Completion Date : April 4, 2022
Estimated Study Completion Date : April 4, 2022

Group/Cohort
Surgery
Patients ≥ 18 years old scheduled for robotic surgery (all specialties except ENT)



Primary Outcome Measures :
  1. NoL index validation [ Time Frame: 7 hours ]
    Area under the curve with the 95% confidence interval, based on the NoL absolute value after nociceptive and non-nociceptive stimuli.


Secondary Outcome Measures :
  1. Discriminative diagnosis performance (nociceptive from non-nociceptive stimuli) of the heart rate after nociceptive and non-nociceptive stimuli. [ Time Frame: 7 hours ]
    Sensitivity, specificity and area under the curve

  2. Discriminative diagnosis performance (nociceptive from non-nociceptive stimuli) of the mean arterial pressure [ Time Frame: 7 hours ]
    Sensitivity, specificity and area under the curve of the mean arterial pressure after nociceptive and non-nociceptive stimuli.

  3. Discriminative diagnosis performance (nociceptive from non-nociceptive stimuli) of the BIS index [ Time Frame: 7 hours ]
    Sensitivity, specificity and area under the curve of the BIS index after nociceptive and non-nociceptive stimuli.

  4. Correlation between the NoL index and the mean arterial pressure during nociceptive stimuli [ Time Frame: 7 hours ]
    Spearman correlation test within the NoL index variations and the mean arterial pressure variations after each stimuli

  5. Correlation between the NoL index and the heart rate during nociceptive stimuli [ Time Frame: 7 hours ]
    Spearman correlation test within the NoL index variations and the heart rate variations after each stimuli

  6. Delay of the NoL index to detect a nociceptive stimuli [ Time Frame: 7 hours ]
    Delay between a NoL index above 25 and the nociceptive stimuli



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing robotic surgery in Bichat Hospital, APHP, Paris, France
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Scheduled for a robotic surgery in the center of investigation (all specialties except cardiac and ENT: gynaecologic, thoracic, urologic and abdominal)
  • Non-opposition to the study participation

Exclusion criteria :

  • Age < 18 years old
  • Rapid sequence anaesthesia required
  • Pregnancy and breast feeding
  • Chronic medication by any pain killer (opioids or not)
  • ENT and cardiac robotic surgery
  • Neuromuscular disease
  • NoL Index contre-indications, such as cardiac arrythmia, supra-clavicular arterial stenosis, severe hypovolemia, severe hypothermia
  • Chronic alcoholism, toxicomania
  • Severe obesity (IMC > 35)
  • Legal protection
  • Opposition to the study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566536


Locations
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France
Hôpital Bichat-Claude Bernard, AP-HP
Paris, France, 75877
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Aurélie GOUEL-CHERON, MD, PhD Hôpital Bichat-Claude Bernard, AP-HP
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04566536    
Other Study ID Numbers: APHP191091
2019-A02744-53 ( Other Identifier: IDRCB )
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
NoL
Nociception
Robotic surgery