Impact of NOL Index Intraoperative Guided Remifentanil Analgesia

Launched by HOPITAL FOCH · May 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to manage pain during abdominal surgeries using a special monitoring device called the PMD-200™. This device has sensors that measure different body signals to determine how much pain a patient might be feeling while under anesthesia. The goal of the study is to see if using this device can help doctors give patients less of a pain medication called remifentanil, while still keeping them comfortable during surgery. By monitoring pain levels more accurately, doctors hope to improve the safety and effectiveness of anesthesia.

To be eligible to participate in this trial, you need to be at least 18 years old and scheduled for a major surgery that will last more than 90 minutes. You should also be in stable health, as determined by a doctor. However, certain individuals, such as pregnant women or those with specific medical conditions, may not be able to participate. Participants will receive the usual care during surgery, but they will also be monitored with the PMD-200™ device, which is designed to enhance their pain management experience. If you or a loved one are interested in participating and meet the criteria, it could be a valuable opportunity to contribute to new ways of improving surgical care.

Gender

ALL

Eligibility 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