Monitoring Nociception Using NoL Index to Reduce Opioid-Related Complications in Laparoscopic Abdominal Surgery
NCT ID: NCT06437743
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
282 participants
OBSERVATIONAL
2024-06-01
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NoL Visible
Patients in this group will undergo laparoscopic abdominal surgery with the nociception level (NoL) monitor visible to the anesthesiologist. The NoL monitor provides an estimation of nociception through a multi-parameter sensor placed on the patient's finger. The anesthesiologist will adjust the doses of analgesic drugs based on the values observed on the NoL monitor, aiming to maintain the values between 10 and 25 during the surgery.
Nociception Level (NoL) Monitor
The NoL Monitor (PMD-200) is a multi-parameter sensor device placed on the patient's finger to estimate nociception levels during surgery. It provides continuous, real-time feedback to the anesthesiologist on the patient's nociception, assisting in the optimization of analgesic drug administration. The monitor integrates parameters such as heart rate variability, skin conductance, and other physiological signals to compute the NoL index, which ranges from 0 to 100, with target values between 10 and 25 for optimal nociception management.
NoL Not Visible
Patients in this group will undergo laparoscopic abdominal surgery with the NoL monitor not visible to the anesthesiologist. The monitor will still be in place and collecting data, but its values will not be displayed during the surgery. The anesthesiologist will manage analgesia based on standard hemodynamic parameters such as heart rate and blood pressure, without access to the NoL values. The intervention includes the same standard anesthetic protocol as the NoL Visible group.
Nociception Level (NoL) Monitor
The NoL Monitor (PMD-200) is a multi-parameter sensor device placed on the patient's finger to estimate nociception levels during surgery. It provides continuous, real-time feedback to the anesthesiologist on the patient's nociception, assisting in the optimization of analgesic drug administration. The monitor integrates parameters such as heart rate variability, skin conductance, and other physiological signals to compute the NoL index, which ranges from 0 to 100, with target values between 10 and 25 for optimal nociception management.
Interventions
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Nociception Level (NoL) Monitor
The NoL Monitor (PMD-200) is a multi-parameter sensor device placed on the patient's finger to estimate nociception levels during surgery. It provides continuous, real-time feedback to the anesthesiologist on the patient's nociception, assisting in the optimization of analgesic drug administration. The monitor integrates parameters such as heart rate variability, skin conductance, and other physiological signals to compute the NoL index, which ranges from 0 to 100, with target values between 10 and 25 for optimal nociception management.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for laparoscopic abdominal surgery
* Undergoing balanced general anesthesia
* ASA physical status I-III
* Signed informed consent
Exclusion Criteria
* Communication barriers
* Multimodal, opioid-free, or regional epidural anesthesia
* ASA IV or V
* Pregnant or breastfeeding women
* Open or emergency abdominal surgery
* Post-surgery transfer to ICU or Recovery Unit
18 Years
ALL
No
Sponsors
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Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
NETWORK
Responsible Party
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Principal Investigators
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Ana Pascual-Bellosta, M.D, Ph.D, Prof.
Role: PRINCIPAL_INVESTIGATOR
Miguel Servet University Hospital
Cristian Aragón-Benedí, M.D, Ph.D
Role: STUDY_CHAIR
Miguel Servet University Hospital
Central Contacts
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References
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Pascual-Bellosta AM, Aragon-Benedi C, Ortega-Lucea SM, Minguez-Braulio L, Buey-Aguilar M, Abad-Gurumeta A, Tamayo-Gomez E, Martinez-Ubieto J; SIMONE Trial Group. Monitoring of nociception by NoL Index and its implication in the reduction of opioid complications in laparoscopic abdominal surgery (SIMONE study): Protocol of a prospective, multicentre, observational cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Jun;72(6):501729. doi: 10.1016/j.redare.2025.501729. Epub 2025 Feb 22.
Other Identifiers
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SIMONE001
Identifier Type: -
Identifier Source: org_study_id