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
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.
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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