Are reductions in oxygen to the brain associated with behavioral changes in children undergoing anesthesia?

Are reductions in cerebral oxygenation associated with postoperative behavioral changes in children undergoing anesthesia?

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11799594

Enrollment

180

Registered

2021-08-26

Start date

2021-09-15

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children 2 - 6 years of age undergoing general anesthesia Surgery

Interventions

Cerebral oxygenation saturation (crSO2) is continuously measured in the operating room starting before anesthesia induction and ending at the end of the procedure when anesthesia has been stopped. The

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children 2 - 6 years of age scheduled for general anesthesia of at least 30 minutes duration

Exclusion criteria

Exclusion criteria: 1. Age 6 years 3. Children with significant neurodevelopmental delay 4. General anesthesia <30 minutes 5. Access to the forehead for the NIRS probe unavailable (e.g. neurosurgery)

Design outcomes

Primary

Measure	Time frame
1. Behavioral changes according to the Post Hospitalization Behavioral Questionnaire (PHBQ) are measured at 7 days after the general anaesthesia 2. crSO2 during the general anaesthesia measured using Near Infrared Spectroscopy (Invos, www.medtronic.com) using an age-appropriate sensor on the forehead	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 18/10/2021: 1. Behavioral changes according to the PHBQ measured at 30 days after the general anesthesia. Similarly, the OR of persistent changes is calculated for crSO2 more or less than 5%. 2. Episodes of hypotension and/or desaturation during anesthesia and PHBQ changes measured using patient records 3. Perioperative behavioural changes: a score of more than 2 of the Pediatric Anesthesia Behavior score at induction and/or a score of more than 14 of the Pediatric Anesthesia Emergence Delirium score in the post-anesthesia care unit. 4. The association between changes in PHBQ and the following biomarkers are investigated at a single time point: 4.1. Neurofilament light chain (NfL) and Glial fibrillary acidic protein (GFAp) measured using Single molecule array (Simoa) technology (Quanterix, Billerica, MA) 4.2. Ubiquitin C-terminal hydrolase L1 (UCHL1), NGAL, KIM-1, NAG measured using commercial immunoflourescence assay panels _____ Previous secondary outcome measures: 1. Behavioral changes according to the PHBQ measured at 30 days after the general anesthesia. Similarly, the OR of persistent changes is calculated for crSO2 more or less than 5%. 2. Episodes of hypotension and/or desaturation during anesthesia and PHBQ changes measured using patient records 3. The association between changes in PHBQ and the following biomarkers are investigated at a single time point: 3.1. Neurofilament light chain (NfL) and Glial fibrillary acidic protein (GFAp) measured using Single molecule array (Simoa) technology (Quanterix, Billerica, MA) 3.2. Ubiquitin C-terminal hydrolase L1 (UCHL1), NGAL, KIM-1, NAG measured using commercial immunoflourescence assay panels	—

Measure

Time frame

Current secondary outcome measures as of 18/10/2021: 1. Behavioral changes according to the PHBQ measured at 30 days after the general anesthesia. Similarly, the OR of persistent changes is calculated for crSO2 more or less than 5%. 2. Episodes of hypotension and/or desaturation during anesthesia and PHBQ changes measured using patient records 3. Perioperative behavioural changes: a score of more than 2 of the Pediatric Anesthesia Behavior score at induction and/or a score of more than 14 of the Pediatric Anesthesia Emergence Delirium score in the post-anesthesia care unit. 4. The association between changes in PHBQ and the following biomarkers are investigated at a single time point: 4.1. Neurofilament light chain (NfL) and Glial fibrillary acidic protein (GFAp) measured using Single molecule array (Simoa) technology (Quanterix, Billerica, MA) 4.2. Ubiquitin C-terminal hydrolase L1 (UCHL1), NGAL, KIM-1, NAG measured using commercial immunoflourescence assay panels _____ Previous secondary outcome measures: 1. Behavioral changes according to the PHBQ measured at 30 days after the general anesthesia. Similarly, the OR of persistent changes is calculated for crSO2 more or less than 5%. 2. Episodes of hypotension and/or desaturation during anesthesia and PHBQ changes measured using patient records 3. The association between changes in PHBQ and the following biomarkers are investigated at a single time point: 3.1. Neurofilament light chain (NfL) and Glial fibrillary acidic protein (GFAp) measured using Single molecule array (Simoa) technology (Quanterix, Billerica, MA) 3.2. Ubiquitin C-terminal hydrolase L1 (UCHL1), NGAL, KIM-1, NAG measured using commercial immunoflourescence assay panels

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Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026