Impact of NOL Index Intraoperative Guided Remifentanil Analgesia

NCT04402242 | Recruiting

• 1 other identifier: 2019_0051
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

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 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

Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Remifentanil consumption during maintenance

  Remifentanil consumption during anesthesia maintenance in μg/kg/min

  surgery day (D0)

Secondary Outcomes (9)

• Remifentanil consumption during induction

  surgery day (D0)

• Propofol consumption during induction

  surgery day (D0)

• Propofol consumption during maintenance

  surgery day (D0)

• Proportion of patients with intraoperative hemodynamic abnormality in the NOL index group compared to standard care group during induction

  surgery day (D0)

• Proportion of patients with intraoperative hemodynamic abnormality in the NOL index group compared to standard care group during maintenance

  surgery day (D0)

Study Arms (2)

"SCS" Group

SHAM COMPARATOR

Receiving anesthesia according to routine standard care, with the use of the "hidden" NOL (used to compare the data at the end of anesthesia with those of the classic BIS - without monitoring of the anesthesia by the NOL (without adjustment of treatments ))

Device: Bispectral index

NOL Group

EXPERIMENTAL

Receiving anesthesia monitored by the NOL

Device: Bispectral index + NOL index

Interventions

Bispectral index DEVICE

Anesthesia monitoring

"SCS" Group

Bispectral index + NOL index DEVICE

Anesthesia monitoring

NOL Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (3)

Hôpital d'Instruction des Armées - Sainte-Anne

Toulon, Provence-Alpes-Côte d'Azur Region, 83800, France

NOT YET RECRUITING

Hopital d'Instruction des Armées de Bégin

Saint-Mandé, Saint Mandé, 94160, France

NOT YET RECRUITING

Foch Hospital

Suresnes, 92150, France

RECRUITING

Related Publications (1)

• Meijer FS, Martini CH, Broens S, Boon M, Niesters M, Aarts L, Olofsen E, van Velzen M, Dahan A. Nociception-guided versus Standard Care during Remifentanil-Propofol Anesthesia: A Randomized Controlled Trial. Anesthesiology. 2019 May;130(5):745-755. doi: 10.1097/ALN.0000000000002634.

  PMID: 30829658 RESULT

MeSH Terms

Interventions

Consciousness Monitors

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Morgan LE GUEN, MD

  Foch HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan LE GUEN, Dr

CONTACT

+33146252998; m.leguen@hopital-foch.com

Elisabeth HULIER AMMAR, Dr

CONTACT

+33146251175; drci-promotion@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, multi-center, single blinded interventional study with 2 parallel groups: standard clinical care (SCC group, control group) and NOL-guided analgesia (NOL guided analgesia group, interventional group), stratified by site

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: May 26, 2020
• Study Start: April 13, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)