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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Pain
• Intervention / Treatment: Procedure: Standard protocol; Procedure: ANI protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Adults female undergoing elective breast surgery
• American Society of Anesthesiologists (ASA) classification I-III
• Body mass index (BMI) 18.5-35 kg/m2

Exclusion Criteria:

• Implanted pacemaker
• Cardiac arrythmia
• Autonomic nervous system (ANS) disorder, e.g. epilepsy, stroke
• Chronic opioid use
• Chronic pain
• On beta-blocker, calcium channel blocker, or other drugs to control arrythmia
• Previous mastectomy
• Pregnancy
• On Nsaids

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Intraoperative fentanyl administration will be guided by standard protocol	Procedure: Standard protocol; Give narcotic according to vital signs
Experimental: ANI group; Intraoperative fentanyl administration will be guided by ANI protocol	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain: NRS	Measure pain numeric rating scale (NRS) every 15 minutes. NRS has a range from 0 to 10 with 0 indicates no pain while 10 indicates worst pain. NRS of 0-3 is mild, 4-6 is moderate, and 7-10 is severe pain.	during 60 minutes in PACU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	Cumulative fentanyl used intraoperatively of both groups	During intraoperative period
Intraoperative ANI score	Intraoperative ANI score of both groups. ANI has a range from 0 to 100 with 0 indicates worst pain while 100 indicates no pain. ANI 0-49 suggests that more opioid is needed. ANI 50-70 indicate optimal analgesic and no opioid is needed. ANI > 70 indicates excessive effect of opioid and opioid should be withheld.	During intraoperative period
Postoperative nausea/vomiting	Nausea/vomiting score (PONV score) every 4 hours. PONV score has a range of 0 to 3. N/V scores 0= none, 1= mild, 2= moderate, and 3= severe PONV.	During 24 hours postoperatively
Postoperative sedation score	Sedation score every 4 hours. Sedation score has a range of 0 to 3 with 0= fully alert, 1= mild sedation, easy to rouse, 2= moderate sedation, arousable with gentle shaking, and 3= deep sedation, not aroused by speaking or gentle shaking.	During 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Principal Investigator: Sirirat Tribuddharat, MD, PhD, Faculty Of Medicine, Khon Kaen University

Publications and helpful links

General Publications

• Boselli E, Bouvet L, Begou G, Dabouz R, Davidson J, Deloste JY, Rahali N, Zadam A, Allaouchiche B. Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study. Br J Anaesth. 2014 Apr;112(4):715-21. doi: 10.1093/bja/aet407. Epub 2013 Dec 8.
• Daccache G, Jeanne M, Fletcher D. The Analgesia Nociception Index: Tailoring Opioid Administration. Anesth Analg. 2017 Jul;125(1):15-17. doi: 10.1213/ANE.0000000000002145. No abstract available.
• Dundar N, Kus A, Gurkan Y, Toker K, Solak M. Analgesia nociception index (ani) monitoring in patients with thoracic paravertebral block: a randomized controlled study. J Clin Monit Comput. 2018 Jun;32(3):481-486. doi: 10.1007/s10877-017-0036-9. Epub 2017 Jun 19.
• Tribuddharat S, Sathitkarnmanee T, Sukhong P, Thananun M, Promkhote P, Nonlhaopol D. Comparative study of analgesia nociception index (ANI) vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration among mastectomy patients. BMC Anesthesiol. 2021 Feb 13;21(1):50. doi: 10.1186/s12871-021-01272-2.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: October 21, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 25, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: HE611339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No