Anesthesia, General Clinical Trial
Official title:
The Impact of Electroencephalogram (EEG) - Guided Inhalational Anesthetic Control on the Occurrence of EEG Discontinuity in Infants: A Prospective Randomized Controlled Trial
This study is a randomized controlled trial to evaluate whether EEG-guided calibration of inhalation agents can reduce occurrence of EEG discontinuity in infants during general anesthesia.
Status | Not yet recruiting |
Enrollment | 78 |
Est. completion date | May 30, 2025 |
Est. primary completion date | March 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 12 Months |
Eligibility | Inclusion Criteria: - Infants who were born as full-term (>37 weeks postconception) and are equal to or less than 12 month old who were scheduled to undergo surgery under general anesthesia using inhalation agents. - Belongs to American Society of Anesthesiologists Physical Status 1 or 2 Exclusion Criteria: - Infants who were born less than 37 weeks postconception or has history of mechanical ventilation immediately after birth - Presence of any genetic disease, chromosomal anomaly or congenital anomaly that can affect brain development - Presence of any disease or disability in central nervous system - History of trauma at head or surgery on brain - History of hypersensitivity to any anesthetic agents - Status of sedation or endotracheal intubation before induction of anesthesia - Inability to attach probes for EEG monitoring - Expectation of operation time as less than 5 minutes - Other conditions that researchers regard as inappropriate for enrollment |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Other |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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Bong CL, Long MHY. Sevoflurane requirements during electroencephalogram (EEG)-guided vs standard anesthesia care in children: A randomized controlled trial. J Clin Anesth. 2023 Jun;86:111071. doi: 10.1016/j.jclinane.2023.111071. Epub 2023 Feb 13. No abstract available. — View Citation
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Gao Z, Zhang J, Wang X, Yao M, Sun L, Ren Y, Qiu D. A retrospective study of electroencephalography burst suppression in children undergoing general anesthesia. Pediatr Investig. 2021 Aug 16;5(4):271-276. doi: 10.1002/ped4.12287. eCollection 2021 Dec. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EEG discontinuity | Incidence of EEG discontinuity (EEG amplitudes < 25uV for more than 2 seconds) | From start of anesthesia to end of anesthesia, Less than 24 hours | |
Secondary | Total duration of EEG discontinuity | Total sum of duration of EEG discontinuity | From start of anesthesia to end of study, Less than 24 hours | |
Secondary | Significant isoelectric EEG | Incidence of significant isoelectric EEG (EEG amplitudes < 10uV for more than 2 seconds) | From start of anesthesia to end of study, Less than 24 hours | |
Secondary | EtSev | Mean end-tidal sevoflurane concentration during anesthesia | From start of anesthesia to end of study, Less than 24 hours | |
Secondary | SEF | Mean spectral edge frequency value during anesthesia | From start of anesthesia to end of study, Less than 24 hours | |
Secondary | PSi | Mean patient state index value during anesthesia | From start of anesthesia to end of study, Less than 24 hours | |
Secondary | Mean blood pressure | Mean blood pressure values during anesthesia measured every 2.5 minutes | From start of anesthesia to end of study, Less than 24 hours | |
Secondary | Heart rate | Heart rate values during anesthesia measured every 2.5 minutes | From start of anesthesia to end of study, Less than 24 hours |
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