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Clinical Trials/KCT0008919
KCT0008919
Recruiting
未知

effects of Fentanyl use based on intraoperative Analgesia Nociception index monitoring on postoperative emergence AgiTation In pediatriC patients (FANATIC) – a pilot study of prospective single-blinded randomized-control trial

Korea University Anam Hospital0 sites60 target enrollmentTBD
ConditionsNot Applicable

Overview

Phase
未知
Intervention
Not specified
Conditions
Not Applicable
Sponsor
Korea University Anam Hospital
Enrollment
60
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional Study
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Pediatric patients aged 2 years or older but less than 7 years, undergoing surgery under general anesthesia at the main hospital, with ASA (American Society of Anesthesiologists) class I or II.
  • Patients for whom the anesthesiologist in the Department of Anesthesiology and Pain Medicine has conducted a pre\-surgical evaluation and obtained written consent from their parents/guardians based on provided information.

Exclusion Criteria

  • Exclusion Criteria:
  • Patients requiring artificial ventilation or endotracheal intubation before or after surgery.
  • Patients for whom further research is not feasible due to a severe emergency situation before or after surgery.
  • Cases where the ANI monitoring signal is not detected in the experimental group or the quality of monitoring is low due to an energy level outside the range of 0\.05 to 0\.25\.
  • Use of drugs during surgery that interfere with the autonomic nervous system response, such as atropine, inhaled beta\-agonists for bronchial asthma, or total intravenous anesthesia (TIVA).
  • Mid\-study Disqualification Criteria:
  • Withdrawal of informed consent by the research subject.
  • Inability to continue the trial due to severe adverse reactions or unexpected incidents.
  • Non\-compliance with planned visits and procedures as specified in the protocol by the research subject.
  • Occurrence of severe complications that make it difficult to continue the trial.

Outcomes

Primary Outcomes

Not specified

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