Monitoring Nociception Using NoL Index to Reduce Opioid-Related Complications in Laparoscopic Abdominal Surgery

NCT06437743 | Not Yet Recruiting

• 1 other identifier: SIMONE001
• Study Type: observational
• Target: 282
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine if optimal intraoperative nociception monitoring using the NoL index can reduce postoperative complications related to opioid use in laparoscopic abdominal surgery. The hypothesis is that guided nociception monitoring decreases opioid-related complications and improves postoperative outcomes.

Conditions

Postoperative Opioid-related Complications

Keywords

Nociception, NoL Index, Opioids, Postoperative Complications, Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Reduction in Postoperative Opioid-Related Complications

  The primary outcome measure will evaluate the incidence of postoperative opioid-related complications in patients undergoing laparoscopic abdominal surgery. Complications include nausea, vomiting, respiratory depression, and opioid-induced hyperalgesia. The study aims to determine if the use of the NoL monitor to guide intraoperative analgesia reduces these complications compared to standard hemodynamic monitoring.

  From the end of surgery up to 48 hours postoperatively

Secondary Outcomes (3)

• Intraoperative Opioid Consumption

  During the surgical procedure

• Postoperative Pain Scores

  At 1, 6, 12, 24, and 48 hours postoperatively

• Length of Hospital Stay

  From admission to discharge, up to 7 days postoperatively

Other Outcomes (1)

• Patient Satisfaction with Pain Management

  At 48 hours postoperatively

Study Arms (2)

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.

Device: Nociception Level (NoL) Monitor

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.

Device: Nociception Level (NoL) Monitor

Interventions

Nociception Level (NoL) Monitor DEVICE

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.

Also known as: PMD-200

NoL Not Visible; NoL Visible

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients scheduled for elective laparoscopic abdominal surgery at participating hospitals. The population will consist of individuals who meet the inclusion criteria and have consented to participate in the study.

You may qualify if:

• Age ≥ 18 years
• Scheduled for laparoscopic abdominal surgery
• Undergoing balanced general anesthesia
• ASA physical status I-III
• Signed informed consent

You may not qualify if:

• Refusal to participate
• 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

Sponsors & Collaborators

• Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon: lead

Related Publications (1)

• 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.

  PMID: 39993632 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Interventions

Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ana Pascual-Bellosta, M.D, Ph.D, Prof.

  Miguel Servet University Hospital

  PRINCIPAL INVESTIGATOR

• Cristian Aragón-Benedí, M.D, Ph.D

  Miguel Servet University Hospital

  STUDY CHAIR

Central Study Contacts

Cristian Aragón-Benedí, M.D, Ph.D

CONTACT

+34625408866; cristianaragon@outlook.com

Ana Pascual-Bellosta, M.D, Ph.D, Prof.

CONTACT

anapascual689@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 31, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share