Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04138966
Other study ID # P2019/427Am1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 20, 2019
Est. completion date December 20, 2020

Study information

Verified date November 2020
Source Erasme University Hospital
Contact Sean Coeckelenbergh, MD
Phone 32 (0) 2 555 39 19
Email secoecke@ulb.ac.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Comparison of twà different nociception monitors during general anesthesia


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 20, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Intervention

Device:
Nol-Index
Multiparametric monitor that studies that establishes an index as a surrogate to nociception
Skin Conductance
Measures skin conductance as a surrogate to nociception

Locations

Country Name City State
Belgium Anesthesia Department, Erasme Hospital Brussels

Sponsors (1)

Lead Sponsor Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nol-Index response Nol-Index (diminsenliss value from 0 to 100) will be assessed during noxious and non noxious stimuli 1 to 2 hours
Primary Skin conductance response Peaks per second change during noxious and non noxious stimuli 1 to 2 hours
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas