Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery
1 other identifier
interventional
48
1 country
1
Brief Summary
This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2019
CompletedStudy Start
First participant enrolled
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJuly 1, 2022
June 1, 2022
2.1 years
October 8, 2019
June 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Remifentanil requirement
µg/kg/hour required during general anesthesia
2 to 8 hours
Secondary Outcomes (11)
Norepinephrine requirement
2 to 8 hours
propofol requirement
2 to 8 hours
nicardipine requirement
2 to 8 hours
esmolol requirement
2 to 8 hours
Intraoperative hemodynamic instability
2 to 8 hours
- +6 more secondary outcomes
Study Arms (2)
Nol-Guided Analgesia Group
EXPERIMENTALIn the Nol-Guided Analgesia Group remifentanil effect site concentration will be adapted to maintain the NOL-index between 10 and 25 throughout the anesthetic.
Standard Analgesia Group
ACTIVE COMPARATORRemifentanil titration in the Standard Analgesia Group will be left at the anesthesiologists discretion (i.e., guided by heart rate, blood pressure, and experience).
Interventions
Monitor that indicates the level of nociception-antinociception balance
Administration of remifentanil based guided by heart rate, blood pressure, and experience
Eligibility Criteria
You may qualify if:
- moderate-to-high risk cardiac or vascular surgery
- ASA 2-4
You may not qualify if:
- chronic arrhythmia (e.g. atrial fibrillation)
- aortic insufficiency
- pacemaker
- implanted defibrillator
- valve surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anesthesia Department, Erasme Hospital
Brussels, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc Barvais, MD, PhD
Erasme University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 24, 2019
Study Start
October 10, 2019
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
July 1, 2022
Record last verified: 2022-06