NCT04963036

Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity

Impact of Nociception Level (NOL)-Guided Remifentanil Infusion and Entropy-guided Propofol Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity A Prospective, Randomized, Controlled Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high risk patients. The investigator will also investigate the effects of guided anesthesia on postoperative Myocardial Injury in Non-cardiac Surgery (MINS) and Postoperative cognitive dysfunction (POCD), amongst other frequent postoperative complications, in this population.

Conditions

• Head and Neck Surgery
• Maxillofacial Surgery

Interventions

Type	Name	Description
OTHER	Entropy and NOL-Guided Goal Directed Anesthesia	Entropy-guided Anesthesia (Propofol infusion in order to maintain Entropy between 45 and 55) and NOL-guided Analgesia (Remifentanil infusion in order to maintain NOL-Index between 10 and 25).
OTHER	Standard of Care Group (Entropy and blinded NOL)	Entropy-guided Anesthesia (Propofol infusion in order to obtain Entropy between 45 and 55) and Remifentanil infusion at the discretion of the anesthetist in charge, based on current practice: patient vitals (Heart Rate, Blood Pressure, Respiratory Rate…), movements, spontaneous breathing, experience.... In this group, nociception monitor screen will be concealed and the NOL index will not be available for guidance of remifentanil dosing).

Timeline

• Start date: 2021-07-28
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2021-07-15
• Last updated: 2022-04-15

Locations

1 site across 1 country: Belgium