Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children (PURFT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Opioid Use
• Intervention / Treatment: Device: Pupillometry

Detailed Description

comparison of total used opioid

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pupillometry group; A group of participants who receive remifentanil infusion under pupillometry monitoring.	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.
NO_INTERVENTION: Conventional group; A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hee-Soo Kim, M.D., Ph.D., Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital

Publications and helpful links

General Publications

• 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;62(8):1050-6. doi: 10.1111/aas.13129. Online 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 4, 2018
• Primary Completion (ANTICIPATED): November 18, 2020
• Study Completion (ANTICIPATED): November 18, 2021

Study Registration Dates

• First Submitted: November 18, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (ACTUAL): November 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 27, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Remifentanil; Analgesia; Pupil dilatory reflex
• Other Study ID Numbers: 1811-036-984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No