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

Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

Status: Not yet enrolling

Conditions: Postoperative Opioid-related Complications

Treatments: Device: Nociception Level (NoL) Monitor

Study type: Observational

Funder types: NETWORK

Identifiers

NCT06437743

SIMONE001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 282 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

282 participants in 2 patient groups

NoL Visible

Description:

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.

Treatment:

Device: Nociception Level (NoL) Monitor

NoL Not Visible

Description:

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.

Treatment:

Device: Nociception Level (NoL) Monitor