Actively Recruiting
Impact of NOL Index Intraoperative Guided Remifentanil Analgesia
Led by Hopital Foch · Updated on 2024-06-14
210
Participants Needed
3
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of NOL Index Intraoperative Guided Remifentanil Analgesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- American Society of Anesthesiologists (ASA) score I, II, or III and stable
- Planned laparotomy or laparoscopy for major digestive, urological, or gynecological surgery under total intravenous anesthesia lasting more than 90 minutes
- Signed informed consent before any study procedures
- Covered by national health insurance
You will not qualify if you...
- Pregnancy or breastfeeding
- Use of antiarrhythmic drugs
- Central nervous system disorders
- Difficult venous access
- Risk of difficult mask ventilation or intubation
- Use of anesthesia other than general anesthesia during surgery (except wall blocks or pericatricial infiltrations performed at the end)
- Allergy or intolerance to study drugs
- Does not understand French
- Deprived of liberty or under guardianship
- Need for succinylcholine administration
- Hemodynamic instability before anesthesia induction (mean arterial pressure < 65 mm Hg or > 110 mm Hg, heart rate < 45/min or > 90/min)
- Use of IV lidocaine or continuous ketamine during anesthesia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hôpital d'Instruction des Armées - Sainte-Anne
Toulon, Provence-Alpes-Côte d'Azur Region, France, 83800
Not Yet Recruiting
2
Hopital d'Instruction des Armées de Bégin
Saint-Mandé, Saint Mandé, France, 94160
Not Yet Recruiting
3
Foch Hospital
Suresnes, France, 92150
Actively Recruiting
Research Team
M
Morgan LE GUEN, Dr
CONTACT
E
Elisabeth HULIER AMMAR, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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