Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716453
• Other study ID #: HE611339
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: November 2019
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications
• Postoperative Pain

Intervention

Procedure:
• Standard protocol
Give narcotic according to vital signs
• 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.

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital, Faculty of Medicine, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

Boselli E, Bouvet L, Bégou 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. d — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intraoperative fentanyl consumption	Cumulative fentanyl used intraoperatively of both groups	During intraoperative period
Secondary	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
Secondary	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
Secondary	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