Efficacy of newborn infant parasympathetic evaluation (NIPE) index versus standard hemodynamic response for guiding intraoperative fentanyl administration in children younger than 2 years

Phase 4

Completed

• Conditions: Children younger than 2 years scheduled for head, neck, or upper extremities surgery under general anesthesia; NIPE, newborn infant parasympathetic evaluation, fentanyl, intraoperative, hemodynamic, guide, ANI, Analgesia nociception index, children, pediatrics

• Registration Number: TCTR20240214002
• Lead Sponsor: Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-01-19
• Study Start: 2024-02-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Children younger than 2 years, ASA classification I-II, scheduled for elective head, neck, or upper extremities surgery undergoing skin incision under general anesthesia

Exclusion Criteria

Refusal of parents, Premature history, Cardiac arrythmia, implanted pacemaker or receiving drugs known to interfere with the autonomic nervous system, Surgical procedure under general anesthesia with additional regional anesthesia or intraoperative ketamine infusion, Planned ICU admission

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain score postoperative Mean (SD), Median (min-max)

Secondary Outcome Measures

Name	Time	Method
Postoperative fentanyl consumption postoperative Mean (SD), Median (min-max) ,Nausea/ vomiting postoperative Percentage,Sedation score postoperative Percentage,Respiratory depression postoperative Percentage