NCT06437743

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

Monitoring Nociception Using NoL Index and Its Implications in Reducing Opioid-Related Complications in Laparoscopic Abdominal Surgery

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 282 (estimated)
• Sponsor: Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a prospective, observational cohort study conducted across multiple centers. It aims to evaluate the impact of intraoperative nociception monitoring on postoperative opioid-related complications. The study will involve two groups of patients undergoing laparoscopic abdominal surgery: one group with visible NoL monitoring and another with non-visible NoL monitoring.

Conditions

• Postoperative Opioid-related Complications

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2024-05-31
• Last updated: 2024-05-31