NCT03716453

Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index

A Comparative Study of Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index Versus Standard Protocol in Patients Undergoing Mastectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Postoperative Pain
• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	Standard protocol	Give narcotic according to vital signs
PROCEDURE	ANI protocol	ANI score 50-70 indicates optimal narcotic effect. ANI score \> 70 indicated overdosage of narcotic and narcotic should be withheld. ANI score \< 50 indicates inadequate narcotic and narcotic should be given.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-05-31
• Completion: 2019-08-30
• First posted: 2018-10-23
• Last updated: 2019-11-27

Locations

1 site across 1 country: Thailand