RecruitingNot ApplicableNCT06104059

NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia

Ιntraoperative Administration of Opioids Guided by the Nociception Level Index NOL in Elective Laparoscopic Surgeries Under General Anesthesia: Effect on Opioid Consumption, Post-operative Pain and Patient Recovery


Sponsor

Attikon Hospital

Enrollment

50 participants

Start Date

Apr 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to investigate the hypothesis that the intraoperative use of the nociception level index NOL can reduce opioid consumption in adult patients undergoing elective laparoscopic surgeries under general anesthesia, as well as to explore its effect on post-operative pain and patient recovery.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

  • Adult patients undergoing planned laparoscopic surgery under general anesthesia.

Exclusion Criteria10

  • Emergency surgery.
  • Pregnancy.
  • Drug or alcohol abuse in the last 6 months.
  • Chronic opioid use or patients with chronic pain.
  • Serious comorbidity \[cardiac disease (atrial fibrillation, ventricular arrhythmias), liver or kidney disease\]
  • Obesity (BMI >35).
  • Permanently implanted pacemaker.
  • Patients with CNS disease.
  • Allergy to any of the study drugs.
  • Patients receiving anticholinergics agonists, α2-adrenergic agonists, β1-adrenergic antagonists, antiarrhythmic drugs.

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Interventions

DEVICENociception level index (NOL™)

If a NOL value \>25 persists for \>1 minute a bolus of iv fentanyl 0.5mcg/kg will be given and reassessment of the NOL value will continue every 5 minutes. If NOL index value: 10-25 is not reached within 10 minutes, fentanyl 0.5mcg/kg iv is re-administered.

OTHERFentanyl

Bolus doses of iv fentanyl 0.5 mcg/kg will be administered based on the judgment of the anesthesiologist in charge.


Locations(1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, Greece

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NCT06104059