NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia

NCT06104059 | Recruiting

• 1 other identifier: NOLGADELS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the hypothesis that the intraoperative use of the nociception level index NOL can reduce opioid consumption in adult patients undergoing elective laparoscopic surgeries under general anesthesia, as well as to explore its effect on post-operative pain and patient recovery.

Conditions

Intraoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Intraoperative total consumption of opioids

  Intraoperative total consumption of opioids will be calculated in all patients.

  Up to 30 minutes after the end of operation

Secondary Outcomes (2)

• Postoperative administration of opioids in PACU

  Until the patient is released from PACU (up to 24 hours)

• Intensity of postoperative pain in PACU

  Until the patient is released from PACU (up to 24 hours)

Study Arms (2)

Nociception level index (NOL™)

ACTIVE COMPARATOR

The nociception level index NOL will be used in order to quide intraopertaive analgesia.

Device: Nociception level index (NOL™)

Standard of care

ACTIVE COMPARATOR

Intraoperative analgesia will be based on common practice, i.e. changes in hemodynamic parameters.

Other: Fentanyl

Interventions

Nociception level index (NOL™) DEVICE

If a NOL value \>25 persists for \>1 minute a bolus of iv fentanyl 0.5mcg/kg will be given and reassessment of the NOL value will continue every 5 minutes. If NOL index value: 10-25 is not reached within 10 minutes, fentanyl 0.5mcg/kg iv is re-administered.

Nociception level index (NOL™)

Fentanyl OTHER

Bolus doses of iv fentanyl 0.5 mcg/kg will be administered based on the judgment of the anesthesiologist in charge.

Standard of care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing planned laparoscopic surgery under general anesthesia.

You may not qualify if:

• Emergency surgery.
• Pregnancy.
• Drug or alcohol abuse in the last 6 months.
• Chronic opioid use or patients with chronic pain.
• Serious comorbidity \[cardiac disease (atrial fibrillation, ventricular arrhythmias), liver or kidney disease\]
• Obesity (BMI \>35).
• Permanently implanted pacemaker.
• Patients with CNS disease.
• Allergy to any of the study drugs.
• Patients receiving anticholinergics agonists, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic drugs.

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

RECRUITING

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

PARASKEVI Prof MATSOTA

CONTACT

6945544563; matsota@yahoo.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Not aware of the study group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof of Anesthesiology

Model Details: Prospective, Randomized clinical trial

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 27, 2023
• Study Start: April 20, 2023
• Primary Completion: September 20, 2025
• Study Completion (Estimated): September 20, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)