Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children

Opioid Use Clinical Trial

— PURFT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03749811
• Other study ID #: 1811-036-984
• Status: Recruiting
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: November 18, 2021

Study information

• Verified date: March 2019
• Source: Seoul National University Hospital
• Contact: Hee-Soo Kim, M.D., Ph.D.
• Phone: +82-2-2072-3664
• Email: dami0605[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

comparison of total used opioid

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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: 1 — View Citation

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] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Emergence time	Time between the end of the surgery and extubation	Intraoperative
Secondary	Incidence of rescue therapy	Incidence of vasopressor/inotropics/anticholinergics/fluid/vasodilators administered, due to moderate to severe hemodynamic change	Intraoperative