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

Seoul National University

Status: Unknown

Conditions: Opioid Use

Treatments: Device: Pupillometry

Study type: Interventional

Funder types: Other

Identifiers

NCT03749811

1811-036-984

Details and patient eligibility

About

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 description

comparison of total used opioid

Enrollment: 60 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Pupillometry group

Experimental group

Description:

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

Treatment:

Device: Pupillometry

Conventional group

No Intervention group

Description:

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