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

Cardiac Surgery Clinical Trial

Official title:

Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137991
• Other study ID #: P2019/427
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: June 2022
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• General Anesthesia
• Goal-directed Therapy
• Hemodynamic Instability
• Nociceptive Pain
• Nol-Index
• Remifentanil
• Vascular Surgery

Intervention

Device:
• Nol-Index guided analgesia
Monitor that indicates the level of nociception-antinociception balance

Other:
• Standard Analgesia
Administration of remifentanil based guided by heart rate, blood pressure, and experience

Locations

Country	Name	City	State
Belgium	Anesthesia Department, Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

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