Clinical trial NCT03716453: Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index
Official title: A Comparative Study of Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index Versus Standard Protocol in Patients Undergoing Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Postoperative Complications
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain: NRS
timeFrame: during 60 minutes in PACU
Secondary outcomes:
measure: Intraoperative fentanyl consumption
timeFrame: During intraoperative period
measure: Intraoperative ANI score
timeFrame: During intraoperative period
measure: Postoperative nausea/vomiting
timeFrame: During 24 hours postoperatively
measure: Postoperative sedation score
timeFrame: During 24 hours postoperatively
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Study officials:
affiliation: Faculty of Medicine, Khon Kaen University
name: Sirirat Tribuddharat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.