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 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年11月13日

试验速览

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•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:
•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.
•Inclusion of subjects who do not meet the selection criteria.
•Inclusion of subjects who meet the exclusion criteria.
•Any other circumstances where the clinical trial personnel determine that continuing the trial would be impractical.
•Additionally, if the research subject does not adhere to the pre-established clinical research procedures, they may be excluded from the clinical trial as per prior notice.

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