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NCT Number: NCT03716453

Intraoperative Fentanyl Consumption Guided by Analgesia Nociception Index

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Srinagarind Hospital, Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Protocol

Procedure

Give narcotic according to vital signs

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.

Primary outcomes

  1. Postoperative pain: NRS

    Time frame: during 60 minutes in PACU

    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.

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: During intraoperative period

    Cumulative fentanyl used intraoperatively of both groups

  2. Intraoperative ANI score

    Time frame: During intraoperative period

    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.

  3. Postoperative nausea/vomiting

    Time frame: During 24 hours postoperatively

    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.

  4. Postoperative sedation score

    Time frame: During 24 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 23, 2018
Registry last updated
Nov 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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