Clinical trial NCT03749811: Pupillometry-guided Remifentanil Infusion Versus Conventional Administration in Children
Official title: Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Keywords: Pupil dilatory reflex
Remifentanil
Analgesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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)
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: remifentanil total dose in microgram
timeFrame: from beginning of anesthesia to the end of the anesthesia
measure: FLACC score
timeFrame: Arrival at the post-anesthesia care unit
measure: Adjusted analgesic dose after anesthesia
timeFrame: 24 hours after the end of anesthesia
Secondary outcomes:
measure: Emergence time
timeFrame: Intraoperative
measure: Incidence of rescue therapy
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Dept. of Anesthesiology and Pain Medicine, Seoul National University Hospital
name: Hee-Soo Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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 Sep;62(8):1050-1056. doi: 10.1111/aas.13129. Epub 2018 Apr 19.
citation: 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.