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Comparing Skin Conductance and Nol-index

NCT ID: NCT04138966

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-20

Study Completion Date

2020-12-20

Brief Summary

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Comparison of twà different nociception monitors during general anesthesia

Detailed Description

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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).

Conditions

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Analgesia Anesthesia Monitoring Vascular Diseases Cardiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing general anesthesia

Patients are monitored with Nol-Index, skin conductance, and antinociception-index

Nol-Index

Intervention Type DEVICE

Multiparametric monitor that studies that establishes an index as a surrogate to nociception

Skin Conductance

Intervention Type DEVICE

Measures skin conductance as a surrogate to nociception

Interventions

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Nol-Index

Multiparametric monitor that studies that establishes an index as a surrogate to nociception

Intervention Type DEVICE

Skin Conductance

Measures skin conductance as a surrogate to nociception

Intervention Type DEVICE

Other Intervention Names

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PMD-200 The PainMonitor Index

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasme University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luc Barvais, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Anesthesia Department, Erasme Hospital

Locations

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Anesthesia Department, Erasme Hospital

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Sean Coeckelenbergh, MD

Role: CONTACT

Phone: 32 (0) 2 555 39 19

Email: [email protected]

Luc Barvais, MD, PhD

Role: CONTACT

Phone: 32 (0) 2 555 39 19

Facility Contacts

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Sean Coeckelenbergh, MD

Role: primary

Other Identifiers

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P2019/427Am1

Identifier Type: -

Identifier Source: org_study_id