Comparing Skin Conductance and Nol-index

• Conditions: Monitoring; Analgesia; Anesthesia; Vascular Diseases; Cardiac Disease
• Interventions: Device: Nol-Index; Device: Skin Conductance

• Registration Number: NCT04138966
• Lead Sponsor: Erasme University Hospital

Brief Summary

Comparison of twà different nociception monitors during general anesthesia

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 Timeline

• Study Start: 2019-10-20
• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Primary Completion: 2020-06-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09
• Study Completion: 2020-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing general anesthesia	Skin Conductance	Patients are monitored with Nol-Index, skin conductance, and antinociception-index
Patients undergoing general anesthesia	Nol-Index	Patients are monitored with Nol-Index, skin conductance, and antinociception-index

Primary Outcome Measures

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

Trial Locations

Locations (1)

Anesthesia Department, Erasme Hospital; 🇧🇪 Brussels, Belgium