Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years
NCT ID: NCT05758090
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2023-03-10
2023-12-31
Brief Summary
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Detailed Description
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The objective of this study is to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group NIPE
Intraoperative fentanyl administration will be guided by NIPE protocol
NIPE monitor
Procedure/Surgery: NIPE protocol. Give intraoperative fentanyl according to NIPE value. NIPE score 50-70 indicates optimal narcotic effect. NIPE score \> 70 indicated overdosage of narcotic and narcotic should be withheld. NIPE score \< 50 indicates inadequate narcotic and narcotic should be given.
Group Control
Intraoperative fentanyl administration will be guided by clinical signs
Control
Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.
Interventions
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NIPE monitor
Procedure/Surgery: NIPE protocol. Give intraoperative fentanyl according to NIPE value. NIPE score 50-70 indicates optimal narcotic effect. NIPE score \> 70 indicated overdosage of narcotic and narcotic should be withheld. NIPE score \< 50 indicates inadequate narcotic and narcotic should be given.
Control
Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.
Eligibility Criteria
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Inclusion Criteria
* ASA Status 1-2
* Undergoing elective surgery of upper part of body
Exclusion Criteria
* Arrhythmia
* Concomitant use of regional anesthesia
* Plan for ICU admission
1 Month
2 Years
ALL
No
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Thepakorn Sathitkarnmanee
Associate Professor
Principal Investigators
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Sirirat Tribuddharat, MD, PhD
Role: STUDY_CHAIR
Khon Kaen University
Locations
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Faculty of Medicine, Khon Kaen University
Khon Kaen, , Thailand
Countries
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References
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Weber F, Roeleveld HG, Geerts NJE, Warmenhoven AT, Schroder R, de Leeuw TG. The heart rate variability-derived Newborn Infant Parasympathetic Evaluation (NIPE) Index in pediatric surgical patients from 0 to 2 years under sevoflurane anesthesia-A prospective observational pilot study. Paediatr Anaesth. 2019 Apr;29(4):377-384. doi: 10.1111/pan.13613. Epub 2019 Mar 21.
Recher M, Boukhris MR, Jeanne M, Storme L, Leteurtre S, Sabourdin N, De Jonckheere J. The newborn infant parasympathetic evaluation in pediatric and neonatology: a literature review. J Clin Monit Comput. 2021 Oct;35(5):959-966. doi: 10.1007/s10877-021-00670-8. Epub 2021 Feb 15.
Lim BG. Nociception monitoring tools using autonomic tone changes for intraoperative analgesic guidance in pediatric patients. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):380-392. doi: 10.17085/apm.2019.14.4.380.
Zhang K, Wang S, Wu L, Song Y, Cai M, Zhang M, Zheng J. Newborn infant parasympathetic evaluation (NIPE) as a predictor of hemodynamic response in children younger than 2 years under general anesthesia: an observational pilot study. BMC Anesthesiol. 2019 Jun 11;19(1):98. doi: 10.1186/s12871-019-0774-y.
Other Identifiers
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HE651243
Identifier Type: -
Identifier Source: org_study_id
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