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

May 25, 2024 updated by: Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 Names:
  • PMD-200
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
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 Names:
  • PMD-200

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the end of surgery up to 48 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Opioid Consumption
Time Frame: During the surgical procedure
This secondary outcome measure will assess the total amount of opioids administered during surgery. The comparison will be made between the group with visible NoL monitoring and the group with standard hemodynamic monitoring.
During the surgical procedure
Postoperative Pain Scores
Time Frame: At 1, 6, 12, 24, and 48 hours postoperatively
Postoperative pain levels will be measured using the Visual Analog Scale (VAS) at various time points post-surgery. The study will compare pain scores between the two groups to evaluate the effectiveness of NoL-guided analgesia.
At 1, 6, 12, 24, and 48 hours postoperatively
Length of Hospital Stay
Time Frame: From admission to discharge, up to 7 days postoperatively
This secondary outcome will measure the duration of hospital stay from admission to discharge following surgery. The aim is to determine if NoL-guided analgesia affects the length of hospitalization.
From admission to discharge, up to 7 days postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction with Pain Management
Time Frame: At 48 hours postoperatively
Patient satisfaction with pain management will be assessed using a standardized questionnaire. The goal is to compare satisfaction levels between the NoL visible group and the standard monitoring group.
At 48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

Investigators

  • Principal Investigator: Ana Pascual-Bellosta, M.D, Ph.D, Prof., Miguel Servet University Hospital
  • Study Chair: Cristian Aragón-Benedí, M.D, Ph.D, Miguel Servet University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 25, 2024

First Submitted That Met QC Criteria

May 25, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 25, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIMONE001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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