Clinical trial NCT04137991: Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery
Official title: Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nociceptive Pain
Goal-directed Therapy
Hemodynamic Instability
Nol-Index
Remifentanil
Cardiac Surgery
Vascular Surgery
General Anesthesia
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Remifentanil requirement
timeFrame: 2 to 8 hours
Secondary outcomes:
measure: Norepinephrine requirement
timeFrame: 2 to 8 hours
measure: propofol requirement
timeFrame: 2 to 8 hours
measure: nicardipine requirement
timeFrame: 2 to 8 hours
measure: esmolol requirement
timeFrame: 2 to 8 hours
measure: Intraoperative hemodynamic instability
timeFrame: 2 to 8 hours
measure: Number of patients with 28 day composite and individual adverse outcomes
timeFrame: 28 days
measure: Heart Rate
timeFrame: 2 to 8 hours
measure: Systolic Blood Pressure
timeFrame: 2 to 8 hours
measure: Diastolic Blood Pressure
timeFrame: 2 to 8 hours
measure: Mean Blood Pressure
timeFrame: 2 to 8 hours
measure: Cardiac Output
timeFrame: 2 to 8 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Anesthesia Department, Erasme Hospital
Study officials:
affiliation: Erasme University Hospital
name: Luc Barvais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: