Comparison of Remifentanil Consumption in Pupillometry-guided Versus Conventional Administration in Pediatric Surgery: a Prospective, Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid Use
- Sponsor
- Seoul National University Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- remifentanil total dose in microgram
- Last Updated
- 7 years ago
Overview
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
Investigators
Hee-Soo Kim
princial investigator
Seoul National University Hospital
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
Outcomes
Primary Outcomes
remifentanil total dose in microgram
Time Frame: from beginning of anesthesia to the end of the anesthesia
Remifentanil total dose divided by anesthesia time (minute) and patient weight (kg).
FLACC score
Time Frame: 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
Time Frame: 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 Outcomes
- Emergence time(Intraoperative)
- Incidence of rescue therapy(Intraoperative)