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
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2018
CompletedFirst Submitted
Initial submission to the registry
October 21, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedNovember 27, 2019
November 1, 2019
8 months
October 21, 2018
November 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Intraoperative fentanyl consumption
During intraoperative period
Intraoperative ANI score
During intraoperative period
Postoperative nausea/vomiting
During 24 hours postoperatively
Postoperative sedation score
During 24 hours postoperatively
Study Arms (2)
Control group
PLACEBO COMPARATORIntraoperative fentanyl administration will be guided by standard protocol
ANI group
EXPERIMENTALIntraoperative fentanyl administration will be guided by ANI protocol
Interventions
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.
Eligibility Criteria
You may qualify if:
- Adults female undergoing elective breast surgery
- American Society of Anesthesiologists (ASA) classification I-III
- Body mass index (BMI) 18.5-35 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002, Thailand
Related Publications (4)
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.
PMID: 24322571RESULTDaccache 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.
PMID: 28628575RESULTDundar 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.
PMID: 28631050RESULTTribuddharat 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.
PMID: 33581721DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sirirat Tribuddharat, MD, PhD
Faculty of Medicine, Khon Kaen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
October 21, 2018
First Posted
October 23, 2018
Study Start
October 1, 2018
Primary Completion
May 31, 2019
Study Completion
August 30, 2019
Last Updated
November 27, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share