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

C

Centre Hospitalier Universitaire Saint Pierre

Status

Unknown

Conditions

Head and Neck Surgery
Maxillofacial Surgery

Treatments

Other: Entropy and NOL-Guided Goal Directed Anesthesia
Other: Standard of Care Group (Entropy and blinded NOL)

Study type

Interventional

Funder types

Other

Identifiers

NCT04963036
B0762021210506

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18
  • Elective high-risk head and neck or maxillo-facial surgery

Exclusion criteria

  • Patient refusal
  • Reduced ejection fraction below 40% and heart failure
  • History of atrial Fibrillation, pulmonary embolism, recent cardioversion, recent cardiac ischemic episode, chronic hypotension, chronic kidney insufficiency (serum creatinine > 1.5)
  • Septic state
  • Baseline heart-rate < 50 or > 90 bpm
  • History of psychiatric disease or medication

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Entropy and NOL-Guided Goal Directed Anesthesia
Experimental group
Treatment:
Other: Entropy and NOL-Guided Goal Directed Anesthesia
Standard of Care Group (Entropy and blinded NOL)
Active Comparator group
Treatment:
Other: Standard of Care Group (Entropy and blinded NOL)

Trial contacts and locations

1

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Central trial contact

Mehdi M'rini, MD; Panayota Kapessidou, MD,PhD

Data sourced from clinicaltrials.gov

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