Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
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|ClinicalTrials.gov Identifier: NCT02645279|
Recruitment Status : Unknown
Verified December 2015 by H. Evren Eker, Baskent University.
Recruitment status was: Active, not recruiting
First Posted : January 1, 2016
Last Update Posted : January 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Trauma Metabolic Disease||Other: oral 30% glucose Drug: IV midazolam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2016|
Active Comparator: oral 30% glucose
oral 30% glucose total 200 mg/kg with 0.5-1 mL increments
Other: oral 30% glucose
30% glucose solution was administered orally through a teat. 1 mL 30% glucose solution was added following placement of the teat into the mouth of the newborn. After suckling of 0.5-1 mL glucose solution, the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added until the newborn kept motionless or asleep.
Active Comparator: IV midazolam
intravenous administration of midazolam 0.1 mg/kg
Drug: IV midazolam
IV 0.1 mg/kg midazolam was administered.MRI was routinely performed and the newborns who did not keep motionless or asleep and had motion artefacts were sedated with intravenous 0.5 mg/kg propofol.
- Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation [ Time Frame: Approximately 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02645279
|Study Chair:||Anis Aribogan, Prof||Baskent University Department of Anesthesiology|