Postoperative Opioid-related ComplicationsSIMONENCT06437743
Monitoring Nociception Using NoL Index to Reduce Opioid-Related Complications in Laparoscopic Abdominal Surgery
An observational study of Postoperative Opioid-related Complications, run by Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Opioid-related Complications
- What is being tested?
- Nociception Level (NoL) Monitor
- Type of treatment
- Medical device
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- Age ≥ 18 years
- Scheduled for laparoscopic abdominal surgery
- Undergoing balanced general anesthesia
- ASA physical status I-III
- Signed informed consent
Who cannot join
- 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 locations and contacts
No sites are listed yet.
Ana Pascual-Bellosta, M.D, Ph.D, Prof. contact
About this study
Official title: 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.
Read the 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.
- Being tested
- Nociception Level (NoL) Monitor
- Keywords
- Nociception, NoL Index, Opioids, Postoperative Complications, Laparoscopic Surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nociception Level (NoL) MonitorDevice
Also called PMD-200
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Nociception Level (NoL) Monitor | |
| 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. Receives: Device: Nociception Level (NoL) Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Postoperative Opioid-Related Complications
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.
Measured: From the end of surgery up to 48 hours postoperatively
Secondary outcomes (3)
Intraoperative Opioid Consumption
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.
Measured: During the surgical procedure
Postoperative Pain Scores
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.
Measured: At 1, 6, 12, 24, and 48 hours postoperatively
Length of Hospital Stay
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.
Measured: From admission to discharge, up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Opioid-related ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ana Pascual-Bellosta, M.D, Ph.D, Prof., Principal investigator, Miguel Servet University HospitalCristian Aragón-Benedí, M.D, Ph.D, Study chair, Miguel Servet University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437743
- Sponsor's protocol ID
- SIMONE001
- Acronym
- SIMONE
- Status last verified
- May 2024
- First submitted
- 25 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers for this study.
Publications
Pascual-Bellosta AM, Aragon-Benedi C, Ortega-Lucea SM, Minguez-Braulio L, Buey-Aguilar M, Abad-Gurumeta A, Tamayo-Gomez E, Martinez-Ubieto J; SIMONE Trial Group. Monitoring of nociception by NoL Index and its implication in the reduction of opioid complications in laparoscopic abdominal surgery (SIMONE study): Protocol of a prospective, multicentre, observational cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Jun;72(6):501729. doi: 10.1016/j.redare.2025.501729. Epub 2025 Feb 22.
PubMed 39993632
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Nociception Using NoL Index and Its Implications in Reducing Opioid-Related Complications in Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06437743
- Acronym / sponsor ID
- SIMONE / SIMONE001
- Keywords
- Nociception, NoL Index, Opioids, Postoperative Complications, Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of AragonResearch network
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NoL Visible | – | Device: Nociception Level (NoL) MonitorPatients 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. |
| NoL Not Visible | – | Device: Nociception Level (NoL) MonitorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Scheduled for laparoscopic abdominal surgery
- Undergoing balanced general anesthesia
- ASA physical status I-III
- Signed informed consent
Key exclusion criteria (7 listed)
- Refusal to participate
- Communication barriers
- Multimodal, opioid-free, or regional epidural anesthesia
- ASA IV or V
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nociception Level (NoL) MonitorAlso: PMD-200The 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. | Device | NoL Not Visible, NoL Visible |
Primary outcome
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.
3 secondary outcomes
Intraoperative Opioid Consumption
Time frame: During the surgical procedure
Postoperative Pain Scores
Time frame: At 1, 6, 12, 24, and 48 hours postoperatively
Length of Hospital Stay
Time frame: From admission to discharge, up to 7 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Derived from this study: PubMed 39993632Pascual-Bellosta AM, Aragon-Benedi C, Ortega-Lucea SM, Minguez-Braulio L, Buey-Aguilar M, Abad-Gurumeta A, Tamayo-Gomez E, Martinez-Ubieto J; SIMONE Trial Group. Monitoring of nociception by NoL Index and its implication in the reduction of opioid complications in laparoscopic abdominal surgery (SIMONE study): Protocol of a prospective, multicentre, observational cohort study. Rev Esp Anestesiol Reanim (Engl Ed). 2025 Jun;72(6):501729. doi: 10.1016/j.redare.2025.501729. Epub 2025 Feb 22.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Pascual-Bellosta, M.D, Ph.D, Prof. contact
Ana Pascual-Bellosta, M.D, Ph.D, Prof. principal investigator
Miguel Servet University Hospital
Cristian Aragón-Benedí, M.D, Ph.D study chair
Miguel Servet University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Opioid-related Complications, run by Investigation Group Anesthesia, Resuscitation, And Perioperative Medicine of Aragon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristian Aragón-Benedí, M.D, Ph.D (+34625408866, cristianaragon@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Postoperative Opioid-Related Complications (time frame: From the end of surgery up to 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06437743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.