Comparing Skin Conductance and Nol-index

Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients

Comparison of twà different nociception monitors during general anesthesia

Study Overview

• Status: Unknown
• Conditions: Vascular Diseases; Analgesia; Anesthesia; Cardiac Disease; Monitoring
• Intervention / Treatment: Device: Nol-Index; Device: Skin Conductance

Detailed Description

Analgesia remains a challenge in anesthesia. Several monitors have shown potential in detecting insufficient analgesia during general anesthesia, but they have not been investigated in patients undergoing cardiac and vascular surgery. In this study, we will compare skin conductance (Medstorm, Norway) and nol-index (Medasense, Israel) w during noxious and non-noxious stimuli. This study is carried out on patients included in another study (Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery).

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Recruiting
    • Anesthesia Department, Erasme Hospital
    • Contact: Sean Coeckelenbergh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing cardiac or vascular surgery

Description

Inclusion Criteria:

• moderate-to-high risk cardiac or vascular surgery
• ASA 2-4

Exclusion Criteria:

• chronic arrhythmia (e.g. atrial fibrillation)
• aortic insufficiency
• pacemaker
• implanted defibrillator
• valve surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing general anesthesia; Patients are monitored with Nol-Index, skin conductance, and antinociception-index	Device: Nol-Index; Multiparametric monitor that studies that establishes an index as a surrogate to nociception; Other Names: PMD-200; Device: Skin Conductance; Measures skin conductance as a surrogate to nociception; Other Names: The PainMonitor Index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nol-Index response	Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli	1 to 2 hours
Skin conductance response	Peaks per second change during noxious and non noxious stimuli	1 to 2 hours

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Luc Barvais, MD, PhD, Anesthesia Department, Erasme Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2019
• Primary Completion (ACTUAL): June 1, 2020
• Study Completion (ANTICIPATED): December 20, 2020

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (ACTUAL): October 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Vascular Diseases
• Other Study ID Numbers: P2019/427Am1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No