Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children

Not Applicable

• Conditions: Opioid Use
• Interventions: Device: Pupillometry

• Registration Number: NCT03749811
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

comparison of total used opioid

Study Timeline

• Study First Submitted: 2018-11-18
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Study Start: 2018-12-04
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29
• Primary Completion: 2020-11-18
• Study Completion: 2021-11-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pupillometry group	Pupillometry	A group of participants who receive remifentanil infusion under pupillometry monitoring.

Primary Outcome Measures

Name	Time	Method
remifentanil total dose in microgram	from beginning of anesthesia to the end of the anesthesia	Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
FLACC score	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of