Monitoring Nociception Using NoL Index and Its Implications in Reducing Opioid-Related Complications in Laparoscopic Abdominal Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Opioid-related Complications
- Sponsor
- Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
- Enrollment
- 282
- Primary Endpoint
- Reduction in Postoperative Opioid-Related Complications
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Reduction in Postoperative Opioid-Related Complications
Time Frame: From the end of surgery up to 48 hours postoperatively
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.
Secondary Outcomes
- 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)
- Intraoperative Opioid Consumption(During the surgical procedure)