## Protocol Section
### Identification Module
**NCT ID:** NCT06437743

**Acronym:** SIMONE

**Brief Title:** Monitoring Nociception Using NoL Index to Reduce Opioid-Related Complications in Laparoscopic Abdominal Surgery

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

#### Organization Study ID Info
**ID:** SIMONE001
#### Organization
**Class:** NETWORK
**Full Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
### Status Module
#### Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NETWORK

**Name:** Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Postoperative Opioid-related Complications

**Keywords:**

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

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 282

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Device: Nociception Level (NoL) Monitor

**Label:** NoL Visible

#### Arm Group 2

**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.

**Intervention Names:**

- Device: Nociception Level (NoL) Monitor

**Label:** NoL Not Visible

### Interventions

#### Intervention 1

**Arm Group Labels:**

- NoL Not Visible

- NoL Visible

**Description:** 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.

**Name:** Nociception Level (NoL) Monitor

**Other Names:**

- PMD-200

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** 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.

**Measure:** Patient Satisfaction with Pain Management

**Time Frame:** At 48 hours postoperatively

#### Primary Outcomes

**Description:** 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.

**Measure:** Reduction in Postoperative Opioid-Related Complications

**Time Frame:** From the end of surgery up to 48 hours postoperatively

#### Secondary Outcomes

**Description:** 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.

**Measure:** Intraoperative Opioid Consumption

**Time Frame:** During the surgical procedure

**Description:** 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.

**Measure:** Postoperative Pain Scores

**Time Frame:** At 1, 6, 12, 24, and 48 hours postoperatively

**Description:** 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.

**Measure:** Length of Hospital Stay

**Time Frame:** From admission to discharge, up to 7 days postoperatively

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cristianaragon@outlook.com

**Name:** Cristian Aragón-Benedí, M.D, Ph.D

**Phone:** +34625408866

**Role:** CONTACT

**Contact 2:**

**Email:** anapascual689@gmail.com

**Name:** Ana Pascual-Bellosta, M.D, Ph.D, Prof.

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Miguel Servet University Hospital

**Name:** Ana Pascual-Bellosta, M.D, Ph.D, Prof.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Miguel Servet University Hospital

**Name:** Cristian Aragón-Benedí, M.D, Ph.D

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

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

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
