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

Not Applicable

Completed

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

• Registration Number: NCT04137991
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-08
• Study Start: 2019-10-10
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-24
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nol-Guided Analgesia Group	Nol-Index guided analgesia	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.
Standard Analgesia Group	Standard Analgesia	Remifentanil titration in the Standard Analgesia Group will be left at the anesthesiologists discretion (i.e., guided by heart rate, blood pressure, and experience).

Primary Outcome Measures

Name	Time	Method
Remifentanil requirement	2 to 8 hours	µg/kg/hour required during general anesthesia

Secondary Outcome Measures

Name	Time	Method
Cardiac Output	2 to 8 hours	cardiac output during anesthesia
Mean Blood Pressure	2 to 8 hours	mean blood pressure during anesthesia
Norepinephrine requirement	2 to 8 hours	µg/kg/hour required during general anesthesia
nicardipine requirement	2 to 8 hours	mg/kg/hour required during general anesthesia
Intraoperative hemodynamic instability	2 to 8 hours	Occurence of hypotension, hypertension, bradycardia or tachycardia
Number of patients with 28 day composite and individual adverse outcomes	28 days	renal failure, cardiac ischemia, ileus, stroke, new onset arrhythmia, etc
Heart Rate	2 to 8 hours	Heart rate during anesthesia
Systolic Blood Pressure	2 to 8 hours	systolic blood pressure during anesthesia
esmolol requirement	2 to 8 hours	mg/kg/hour required during general anesthesia
propofol requirement	2 to 8 hours	mg/kg/hour required during general anesthesia
Diastolic Blood Pressure	2 to 8 hours	diastolic blood pressure during anesthesia

Trial Locations

Locations (1)

Anesthesia Department, Erasme Hospital; 🇧🇪 Brussels, Belgium