Postoperative Pain Clinical Trial
Official title:
A Comparative Study of Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index Versus Standard Protocol in Patients Undergoing Mastectomy
Balanced anesthesia needs optimization of hypnotic, relaxant, and narcotic. Administration of hypnotic drugs can be monitored by bispectral index score (BIS), while the dosage of muscle relaxants can be guided by train-of four (TOF). However, administration of narcotics lacks objective monitor. Overdosage of narcotic may lead to delayed awakening, while underdosage may lead to high degree of postoperative pain. Recently, there is a monitor, Analgesic Nociceptive Index (ANI) monitor, designed to guide the administration of narcotics. There are many descriptive studies supporting the correlation of ANI score and pain score but there are still very few randomized control studies which report the efficacy of ANI in clinical practice.
Objective: To evaluate the efficacy of ANI to guide the administration of intraoperative
fentanyl.
Methods: Sixty female patients undergoing breast surgery with balanced anesthesia will be
randomized into 2 groups. The first group will receive fentanyl according to standard
practice of attending anesthesiologists. The second group will receive fentanyl according to
ANI score protocol.
Primary outcome: Postoperative pain numeric rating scale (NRS) score during 60 minutes in
postanesthetic care unit (PACU).
Secondary outcomes: Total intraoperative dose of fentanyl and postoperative nausea/vomiting
and sedation score in PACU.
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