RecruitingNot ApplicableNCT04402242

Impact of NOL Index Intraoperative Guided Remifentanil Analgesia

Impact of Nociceptive-Level (NOL) Intraoperative Guided Remifentanil Analgesia Versus Standard Clinical Care (SCC) for Elective Major Abdominal Surgery

Sponsor

Hopital Foch

Enrollment

210 participants

Start Date

Apr 13, 2021

Study Type

INTERVENTIONAL

Conditions

Abdominal surgery

Summary

The Physiological Monitoring Device (PMD-200™) system is comprised of a monitor and a designated finger probe containing 4 sensors. The sensors included are Photoplethysmography (PPG), Galvanic Skin Response (GSR), Accelerometer for movement (ACC) and Thermistor for peripheral temperature (TMP). The PMD-200 is intended to be used for assessing the nociception level in anesthetized patients. The purpose of the study is confirmation of a reduction in the dosage of remifentanil allowed by the monitoring of nociception by the NOL which could open the way to a double control of the administration of anesthetic agents: control of the administration of hypnotics by the bispectral index (BIS) and control of the administration of opiate by the NOL.

Eligibility

Min Age: 18 Years

Inclusion Criteria14

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
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 Criteria4

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

Interested in this trial?

Get notified about updates and connect with the research team.