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Trial · NCT04415905

Registered outcomes32

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryONSDbefore (T0) caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
PrimaryONSDimmediately after (T1) caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
PrimaryONSD10 minutes (T2) after caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
PrimaryONSD30 minutes (T3) after caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
SecondaryThe variables affecting ICP : Heart rate (beats per minute)before (T0) caudal block.
SecondaryThe variables affecting ICP : Heart rate (beats per minute)immediately after (T1) caudal block.
SecondaryThe variables affecting ICP : Heart rate (beats per minute)10 minutes (T2) after caudal block.
SecondaryThe variables affecting ICP : Heart rate (beats per minute)30 minutes (T3) after caudal block.
SecondaryThe variables affecting ICP : Mean arterial pressure (mmHg)before (T0) caudal block.
SecondaryThe variables affecting ICP : Mean arterial pressure (mmHg)immediately after (T1) caudal block.
SecondaryThe variables affecting ICP : Mean arterial pressure (mmHg)10 minutes (T2) after caudal block.
SecondaryThe variables affecting ICP : Mean arterial pressure (mmHg)30 minutes (T3) after caudal block.
SecondaryThe variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)before (T0) caudal block.
SecondaryThe variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)immediately after (T1) caudal block.
SecondaryThe variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)10 minutes (T2) after caudal block.
SecondaryThe variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)30 minutes (T3) after caudal block.
SecondaryThe variables affecting ICP : End-tidal sevoflurane concentration (volume %)before (T0) caudal block.
SecondaryThe variables affecting ICP : End-tidal sevoflurane concentration (volume %)immediately after (T1) caudal block.
SecondaryThe variables affecting ICP : End-tidal sevoflurane concentration (volume %)10 minutes (T2) after caudal block.
SecondaryThe variables affecting ICP : End-tidal sevoflurane concentration (volume %)30 minutes (T3) after caudal block.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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