Status:
RECRUITING
Impact of NOL Index Intraoperative Guided Remifentanil Analgesia
Lead Sponsor:
Hopital Foch
Conditions:
Abdominal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 R...
Detailed Description
The PMD-200 continuous pain monitor is intended to be used for assessing changes in pain levels. The system monitors the physiological responses to pain using a relative pain index from 0-100, called ...
Eligibility Criteria
Inclusion
- 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-
- 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
- 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
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04402242
Start Date
April 13 2021
End Date
May 1 2025
Last Update
June 14 2024
Active Locations (3)
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1
Hôpital d'Instruction des Armées - Sainte-Anne
Toulon, Provence-Alpes-Côte d'Azur Region, France, 83800
2
Hopital d'Instruction des Armées de Bégin
Saint-Mandé, Saint Mandé, France, 94160
3
Foch Hospital
Suresnes, France, 92150