Opioid Use
Conditions
Keywords
Pupil dilatory reflex, Remifentanil, Analgesia
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
Interventions
DEVICEPupillometry
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
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)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactHee-Soo Kim, M.D., Ph.D.
Backup ContactSang-Whan Ji
Outcome results
None listed