Using a new device to guide pain management during abdominal surgery
Impact of Nociceptive-Level (NOL) Intraoperative Guided Remifentanil Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery
This study is testing a new device that helps doctors manage pain better during abdominal surgery by adjusting medication based on real-time pain signals from patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hopital Foch Academic / other |
| Locations | 3 sites (Toulon, Provence-Alpes-Côte d'Azur Region and 2 other locations) |
| Trial ID | NCT04402242 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the PMD-200™ system, which monitors nociception levels in anesthetized patients undergoing abdominal surgery. By utilizing a combination of sensors, the device provides a Nociception Level (NOL) index that helps adjust the dosage of remifentanil, an opioid analgesic, based on real-time pain assessment. The goal is to reduce the amount of remifentanil needed while maintaining effective pain control, potentially leading to fewer side effects such as hypotension. The study compares standard care with NOL-guided analgesia in patients undergoing major surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for major abdominal surgery requiring general anesthesia.
Not a fit: Patients who are pregnant, have central nervous system disorders, or are at risk for difficult intubation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced side effects for patients undergoing abdominal surgery.
How similar studies have performed: Previous studies have shown promising results with NOL-guided analgesia, indicating potential benefits in pain management during surgery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years old * American Society of Anesthesiologists score (ASA) I, II or III stable * Laparotomy or laparoscopy for major, planned, digestive, urological or gynecological surgery under total intravenous anesthesia (expected total duration \> 90 minutes) * Having sign an informed consent form prior to any study specific procedure * Being covered by a national health insurance Non-Inclusion Criteria: * Pregnancy/lactation * Patient with antiarrhythmic agents * Patient with Central nervous system disorder * Patient with veinous approach difficulties * Patient at risk of difficult mask ventilation or difficult intubation * Concomitant use of any type of anesthesia other than general anesthesia (epidural anesthesia, spinal anesthesia, wall block, pericatricial infiltration). Wall blocks and pericatricial infiltrations are allowed if they are carried out at the end of the intervention * Allergy or intolerance to any of the study drugs * Patient not understanding French language * Being deprived of liberty or under guardianship Exclusion Criteria: * Patient requiring the administration of succinylcholine * Patient with hemodynamic abnormality just before induction of anesthesia (mean arterial pressure \< 65 mm Hg or \> 110 mm Hg, heart rate \< 45/min or \> 90/min * Concomitant use of any type of anesthesia other than general anesthesia (epidural anesthesia, spinal anesthesia, wall block, pericatricial infiltration). Wall blocks and pericatricial infiltrations are allowed if they are carried out at the end of the intervention * Concomitant use of IV lidocaine or continuous ketamine (IV, SE) during anaesthesia
Where this trial is running
Toulon, Provence-Alpes-Côte d'Azur Region and 2 other locations
- Hôpital d'Instruction des Armées - Sainte-Anne — Toulon, Provence-Alpes-Côte d'Azur Region, France (Not_yet_recruiting)
- Hopital d'Instruction des Armées de Bégin — Saint-Mandé, Saint Mandé, France (Not_yet_recruiting)
- Foch Hospital — Suresnes, France (Recruiting)
Study contacts
- Principal investigator: Morgan LE GUEN, MD — Foch HOSPITAL
- Study coordinator: Morgan LE GUEN, Dr
- Email: m.leguen@hopital-foch.com
- Phone: +33146252998
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.