None listed
Conditions
Interventions
Medical Device : "All pediatric patients for whom informed consent has been obtained are admitted to the lead investigator's operating room. The patients undergo standard monitoring, which includes he
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
All
Inclusion 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence Rate (%) of Emergence Agitation in Pediatric Patients after Surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| LACC scale, which is an indicator for assessing a child's pain;Presence of Nausea, Vomiting in Pediatric Patients and Other Adverse Effects | — |
Countries
Korea, Republic of
Contacts
Public ContactEunji Ko
Korea University Anam Hospital
Outcome results
None listed