NCT05758090

Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years

Comparison of Newborn Infant Parasympathetic Evaluation (NIPE) Index Versus Standard Hemodynamic Response for Guiding Intraoperative Fentanyl Administration in Children Younger Than 2 Years Under General Anesthesia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 1 Month – 2 Years
• Healthy volunteers: Not accepted

Summary

During general anesthesia, objective monitoring for analgesia is still lacking. The administration of opioids relies on the experience of the anesthesiologist. There are some monitors, e.g., Analgesia Nociception Index (ANI), showing that they can evaluate analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor was released for assessing analgesia in children with age less than 2 years. The investigators aim to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.

Detailed description

During balanced anesthesia, hypnosis can be monitored with BIS, muscle relaxation can be monitored with a train-of-four, however, analgesia lacks precise monitoring. The anesthesiologist administers narcotics according to clinical signs and experience. Analgesia Nociception Index (ANI) has been introduced as an objective monitor for analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor has been introduced to assess analgesia in children under 2 years, however, clinical studies regarding its clinical efficacy are scarce. 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

• Post Operative Pain
• Analgesia
• Children, Only
• Narcotic Use

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	Control	Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.

Timeline

• Start date: 2023-03-10
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2023-03-07
• Last updated: 2024-04-23

Locations

1 site across 1 country: Thailand