Nociceptive PainNCT04137991
Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery
A study testing Nol-Index guided analgesia and Standard Analgesia in people with Nociceptive Pain and Goal-directed Therapy, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nociceptive Pain, Goal-directed Therapy, Hemodynamic Instability
- What is being tested?
- Nol-Index guided analgesia and Standard Analgesia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Oct 2019to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate-to-high risk cardiac or vascular surgery
- ASA 2-4
Who cannot join
- chronic arrhythmia (e.g. atrial fibrillation)
- aortic insufficiency
- pacemaker
- implanted defibrillator
- valve surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery: a Randomized Controlled Trial
This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.
Read the detailed description
Justification:
Moderate-to-high risk cardiovascular surgery is associated with perioperative morbidity and mortality. These patients undergo general anesthesia and often require tight blood pressure control (e.g., using norepinephrine titration) to avoid the complications associated with hypotension and reduced cardiac output. Standard analgesia opioid titration to control nociception (i.e., the patient's unconscious response to noxious stimuli) is based on the anesthesiologist's experience and variations in the patient's heart rate and blood pressure. This causes anesthesiologists to often give too much analgesic, which can lead to inhibition of the sympathetic autonomic nervous system, hypotension, and associated side effects. A recently developed nociception monitor, the PMD-200 (Medasense, Israel), is capable of measuring the patient's level of nociception-antinociception balance and can guide opioid administration. This monitor may allow anesthesiologists to administer only the required amount of opioid, which may lead to better hemodynamic stability and better postoperative outcome.
Objectives:
The goal of this study is to determine if titrating analgesia using the Nol-Index, when compared to standard care, leads to decreased infused remifentanil, decreased norepinephrine, increased cardiac output, more stable blood pressure control, and decreased postoperative complications in moderate-to-high risk patients undergoing cardiac or vascular surgery.
- Conditions
- Nociceptive Pain, Goal-directed Therapy, Hemodynamic Instability, Nol-Index, Remifentanil, Cardiac Surgery
- Being tested
- Nol-Index guided analgesia, Standard Analgesia
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nol-Index guided analgesiaDevice
Monitor that indicates the level of nociception-antinociception balance
Standard AnalgesiaOther
Administration of remifentanil based guided by heart rate, blood pressure, and experience
| Study group | Role | What they receive |
|---|---|---|
| Nol-Guided Analgesia Group | Experimental | In the Nol-Guided Analgesia Group remifentanil effect site concentration will be adapted to maintain the NOL-index between 10 and 25 throughout the anesthetic. Receives: Device: Nol-Index guided analgesia |
| Standard Analgesia Group | Active comparator | Remifentanil titration in the Standard Analgesia Group will be left at the anesthesiologists discretion (i.e., guided by heart rate, blood pressure, and experience). Receives: Other: Standard Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil requirement
µg/kg/hour required during general anesthesia
Measured: 2 to 8 hours
Secondary outcomes (11)
Norepinephrine requirement
µg/kg/hour required during general anesthesia
Measured: 2 to 8 hours
propofol requirement
mg/kg/hour required during general anesthesia
Measured: 2 to 8 hours
nicardipine requirement
mg/kg/hour required during general anesthesia
Measured: 2 to 8 hours
esmolol requirement
mg/kg/hour required during general anesthesia
Measured: 2 to 8 hours
Intraoperative hemodynamic instability
Occurence of hypotension, hypertension, bradycardia or tachycardia
Measured: 2 to 8 hours
Number of patients with 28 day composite and individual adverse outcomes
renal failure, cardiac ischemia, ileus, stroke, new onset arrhythmia, etc
Measured: 28 days
Heart Rate
Heart rate during anesthesia
Measured: 2 to 8 hours
Systolic Blood Pressure
systolic blood pressure during anesthesia
Measured: 2 to 8 hours
Diastolic Blood Pressure
diastolic blood pressure during anesthesia
Measured: 2 to 8 hours
Mean Blood Pressure
mean blood pressure during anesthesia
Measured: 2 to 8 hours
Cardiac Output
cardiac output during anesthesia
Measured: 2 to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study start10 Oct 2019
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc Barvais, MD, PhD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137991
- Sponsor's protocol ID
- P2019/427
- Status last verified
- Jun 2022
- First submitted
- 8 Oct 2019
- Last updated
- 1 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04137991
- Acronym / sponsor ID
- P2019/427
- Conditions
- Nociceptive Pain, Goal-directed Therapy, Hemodynamic Instability, Nol-Index, Remifentanil, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 24 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.
Detailed description
Justification:
Moderate-to-high risk cardiovascular surgery is associated with perioperative morbidity and mortality. These patients undergo general anesthesia and often require tight blood pressure control (e.g., using norepinephrine titration) to avoid the complications associated with hypotension and reduced cardiac output. Standard analgesia opioid titration to control nociception (i.e., the patient's unconscious response to noxious stimuli) is based on the anesthesiologist's experience and variations in the patient's heart rate and blood pressure. This causes anesthesiologists to often give too much analgesic, which can lead to inhibition of the sympathetic autonomic nervous system, hypotension, and associated side effects. A recently developed nociception monitor, the PMD-200 (Medasense, Israel), is capable of measuring the patient's level of nociception-antinociception balance and can guide opioid administration. This monitor may allow anesthesiologists to administer only the required amount of opioid, which may lead to better hemodynamic stability and better postoperative outcome.
Objectives:
The goal of this study is to determine if titrating analgesia using the Nol-Index, when compared to standard care, leads to decreased infused remifentanil, decreased norepinephrine, increased cardiac output, more stable blood pressure control, and decreased postoperative complications in moderate-to-high risk patients undergoing cardiac or vascular surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nol-Guided Analgesia Group | Experimental | Device: Nol-Index guided analgesiaIn 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 comparator | Other: Standard AnalgesiaRemifentanil titration in the Standard Analgesia Group will be left at the anesthesiologists discretion (i.e., guided by heart rate, blood pressure, and experience). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- moderate-to-high risk cardiac or vascular surgery
- ASA 2-4
Key exclusion criteria (5 listed)
- chronic arrhythmia (e.g. atrial fibrillation)
- aortic insufficiency
- pacemaker
- implanted defibrillator
- valve surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nol-Index guided analgesiaMonitor that indicates the level of nociception-antinociception balance | Device | Nol-Guided Analgesia Group |
| Standard AnalgesiaAdministration of remifentanil based guided by heart rate, blood pressure, and experience | Other | Standard Analgesia Group |
Primary outcome
Remifentanil requirement
Time frame: 2 to 8 hours
µg/kg/hour required during general anesthesia
11 secondary outcomes
Norepinephrine requirement
Time frame: 2 to 8 hours
propofol requirement
Time frame: 2 to 8 hours
nicardipine requirement
Time frame: 2 to 8 hours
esmolol requirement
Time frame: 2 to 8 hours
Intraoperative hemodynamic instability
Time frame: 2 to 8 hours
Number of patients with 28 day composite and individual adverse outcomes
Time frame: 28 days
Heart Rate
Time frame: 2 to 8 hours
Systolic Blood Pressure
Time frame: 2 to 8 hours
Diastolic Blood Pressure
Time frame: 2 to 8 hours
Mean Blood Pressure
Time frame: 2 to 8 hours
Cardiac Output
Time frame: 2 to 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Barvais, MD, PhD principal investigator
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nol-Index guided analgesia and Standard Analgesia in people with Nociceptive Pain and Goal-directed Therapy, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remifentanil requirement (time frame: 2 to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.