Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; General Anesthesia; Hemodynamic Instability; Nociceptive Pain; Goal-directed Therapy; Nol-Index; Remifentanil; Vascular Surgery
• Intervention / Treatment: Device: Nol-Index guided analgesia; Other: Standard Analgesia

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium
    • Anesthesia Department, Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nol-Guided Analgesia Group; 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.	Device: Nol-Index guided analgesia; Monitor that indicates the level of nociception-antinociception balance
Active Comparator: Standard Analgesia Group; Remifentanil titration in the Standard Analgesia Group will be left at the anesthesiologists discretion (i.e., guided by heart rate, blood pressure, and experience).	Other: Standard Analgesia; Administration of remifentanil based guided by heart rate, blood pressure, and experience

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanil requirement	µg/kg/hour required during general anesthesia	2 to 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Norepinephrine requirement	µg/kg/hour required during general anesthesia	2 to 8 hours
propofol requirement	mg/kg/hour required during general anesthesia	2 to 8 hours
nicardipine requirement	mg/kg/hour required during general anesthesia	2 to 8 hours
esmolol requirement	mg/kg/hour required during general anesthesia	2 to 8 hours
Intraoperative hemodynamic instability	Occurence of hypotension, hypertension, bradycardia or tachycardia	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	28 days
Heart Rate	Heart rate during anesthesia	2 to 8 hours
Systolic Blood Pressure	systolic blood pressure during anesthesia	2 to 8 hours
Diastolic Blood Pressure	diastolic blood pressure during anesthesia	2 to 8 hours
Mean Blood Pressure	mean blood pressure during anesthesia	2 to 8 hours
Cardiac Output	cardiac output during anesthesia	2 to 8 hours

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Principal Investigator: Luc Barvais, MD, PhD, Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): November 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 1, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nociceptive Pain
• Other Study ID Numbers: P2019/427

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No