• Sirirat Tribuddharat, Thepakorn Sathitkarnmanee, Pornlada Sukhong, Maneerat Thananun, Parinda Promkhote, and Duangthida Nonlhaopol.
• Department of Anesthesiology, Faculty of Medicine, Khon Kaen University, 123 Mitrapap road, Ampur Muang, Khon Kaen, 40002, Thailand.
• BMC Anesthesiol. 2021 Feb 13; 21 (1): 50.

BackgroundThe Analgesia Nociception Index (ANI) has been suggested as a non-invasive guide for analgesia. Our objective was to compare the efficacy of ANI vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration.MethodsThis was a prospective, randomized, controlled study of adult female patients undergoing elective mastectomy under general anesthesia. The patients were randomized to the ANI-guided group receiving a loading dose of 75 μg of fentanyl followed by 25 μg when the ANI score was under 50. The Control group received the same loading dose followed by 25 μg every 30 min with additional doses when there were signs of inadequate analgesia (viz., tachycardia or hypertension).ResultsSixty patients-30 in each group-were recruited. Although the actual mean ANI score was higher in the ANI-guided than in the Control group (mean difference 2.2; 95% CI: 0.3 to 4.0, P = 0.022), there was no difference in the primary outcome-i.e., intraoperative fentanyl consumption (mean difference - 4.2 μg; 95% CI: - 24.7 to 16.4, P = 0.686 and - 0.14 μg·kg- 1·h- 1; 95% CI: - 0.31 to 0.03, P = 0.105). No difference between groups was shown for either intraoperative blood pressure and heart rate, or for postoperative outcomes (i.e., pain scores, morphine consumption, or sedation scores) in the postanesthesia care unit.ConclusionsIntraoperative fentanyl administration guided by ANI was equivalent to that guided by a modified pharmacologic pattern. In a surgical model of mastectomy, the ANI-guided intraoperative administration of fentanyl had no impact on clinical outcomes.Trial RegistrationThe study was registered with ClinicalTrials.gov ( NCT03716453 ) on 21/10/2018.

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