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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Intraoperative fentanyl administration will be guided by standard protocol |
|
| ANI group | Experimental | Intraoperative fentanyl administration will be guided by ANI protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard protocol | Procedure | Give narcotic according to vital signs |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sirirat Tribuddharat, MD, PhD | Khon Kaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Srinagarind Hospital, Faculty of Medicine, Khon Kaen University | Khon Kaen | 40002 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24322571 | Result | 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. | |
| 28628575 | Result |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C077194 | AIEOP acute lymphoblastic leukemia protocol |
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| ANI protocol |
| Procedure |
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. |
|
| 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 |
| 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. |
| 28631050 | Result | 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. |
| 33581721 | Derived | 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. |
| D012816 | Signs and Symptoms |