Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children

NCT03749811 | Unknown DMC

• 1 other identifier: 1811-036-984
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use

Keywords

Pupil dilatory reflex; Remifentanil; Analgesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Emergence time

  Intraoperative

• Incidence of rescue therapy

  Intraoperative

Study Arms (2)

Pupillometry group

EXPERIMENTAL

A group of participants who receive remifentanil infusion under pupillometry monitoring.

Device: Pupillometry

Conventional group

NO INTERVENTION

A group of participants who receive remifentanil infusion without pupillometry monitoring; their analgesic dose is mainly determined via hemodyamic change.

Interventions

Pupillometry DEVICE

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.

Pupillometry group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (2)

• 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 Sep;62(8):1050-1056. doi: 10.1111/aas.13129. Epub 2018 Apr 19.

  PMID: 29671874 RESULT

• 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.

  PMID: 28719527 RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hee-Soo Kim, M.D., Ph.D.

  Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee-Soo Kim, M.D., Ph.D.

CONTACT

+82-2-2072-3664; dami0605@snu.ac.kr

Sang-Whan Ji

CONTACT

+82-2-2072-3661; taepoongshin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant does not know in which of the groups he/she is allocated. Only a care provider (an attending anesthesiologist who is responsible for the patient's anesthesia) knows the group which the patient belongs to. Investigator and outcomes assessor does not know in which of the groups the patient is allocated, since the group name will be just recorded as "A" or "B" until data analysis of the last participant is done.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: princial investigator

Model Details: Interventional group: remifentanil infusion under pupillometry monitoring. Control group: remifentanil infusion without pupillometry monitoring (remifentanil dose is determined by conventional method, i. e., hemodynamic change probably related to noxious stimuli)

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 21, 2018
• Study Start: December 4, 2018
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2021
• Last Updated: March 29, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)