Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children

Overview

Our study aims to compare the total intravenous dose of remifentanil per anesthesia hour and body weight in two groups of pediatric surgical patients – an interventional group with remifentanil infusion under pupillometry monitoring, and control group without pupillometry – to figure out whether pupillometry monitoring may reduce remifentanil consumption during anesthesia while providing sufficient analgesia for surgical noxious stimuli.

Full Title of Study: “Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 18, 2020

Detailed Description

comparison of total used opioid

Interventions

  • Device: Pupillometry
    • After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant’s pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.

Arms, Groups and Cohorts

  • Experimental: Pupillometry group
    • A group of participants who receive remifentanil infusion under pupillometry monitoring.
  • No Intervention: Conventional group
    • A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.

Clinical Trial Outcome Measures

Primary Measures

  • remifentanil total dose in microgram
    • Time Frame: from beginning of anesthesia to the end of the anesthesia
    • Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
  • FLACC score
    • Time Frame: Arrival at the post-anesthesia care unit
    • FLACC score (a pain evaluation method for children who cannot express their severity of pain verbally) right after post-anesthesia care unit arrival.
  • Adjusted analgesic dose after anesthesia
    • Time Frame: 24 hours after the end of anesthesia
    • Total dose of analgesics (NSAIDs and opioids) delivered to the patient since the end of the anesthesia, until 24 hours after the end of anesthesia

Secondary Measures

  • Emergence time
    • Time Frame: Intraoperative
    • Time between the end of the surgery and extubation
  • Incidence of rescue therapy
    • Time Frame: Intraoperative
    • Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change

Participating in This Clinical Trial

Inclusion Criteria

  • Pediatric patients who are at 3 to 6 years of age, scheduled to undergo elective surgery with estimated time of operation 2 hours or longer, under general anesthesia
  • American Society of Anesthesiologists physical status classification (ASA class) I II
  • Patient and his/her parents are willing to participate after explanation of the purpose, materials, methods, possible risks and benefits of the research

Exclusion Criteria

  • History of hypersensitivity/allergic reaction to the drugs which are used in general anesthesia
  • Preoperative use of analgesics, antipsychotics and/or antiepileptics
  • Mental retardation
  • Medications related to hindrance of autonomic nerve system activity, e. g., beta blockers
  • Underlying ophthalmic diseases

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hee-Soo Kim, princial investigator – Seoul National University Hospital
  • Overall Official(s)
    • Hee-Soo Kim, M.D., Ph.D., Principal Investigator, Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital
  • Overall Contact(s)
    • Hee-Soo Kim, M.D., Ph.D., +82-2-2072-3664, dami0605@snu.ac.kr

Citations Reporting on Results

Wildemeersch D, Peeters N, Saldien V, Vercauteren M, Hans G. Pain assessment by pupil dilation reflex in response to noxious stimulation in anaesthetized adults. Acta Anaesthesiol Scand. 2018 Apr 19. doi: 10.1111/aas.13129. [Epub ahead of print]

Sabourdin N, Barrois J, Louvet N, Rigouzzo A, Guye ML, Dadure C, Constant I. Pupillometry-guided Intraoperative Remifentanil Administration versus Standard Practice Influences Opioid Use: A Randomized Study. Anesthesiology. 2017 Aug;127(2):284-292. doi: 10.1097/ALN.0000000000001705.

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