Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates

NCT02645279 | Unknown Phase 4

• 1 other identifier: KA15/19
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to demonstrate the effectiveness of oral glucose administration during MRI for imaging of newborns and compare with midazolam sedation.

Conditions

Epilepsy; Trauma; Metabolic Disease

Keywords

newborn; MRI; oral 30% glucose

Outcome Measures

Primary Outcomes (1)

• 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

  Approximately 1 year

Study Arms (2)

oral 30% glucose

ACTIVE COMPARATOR

oral 30% glucose total 200 mg/kg with 0.5-1 mL increments

Other: oral 30% glucose

IV midazolam

ACTIVE COMPARATOR

intravenous administration of midazolam 0.1 mg/kg

Drug: IV midazolam

Interventions

oral 30% glucose OTHER

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.

oral 30% glucose

IV midazolam DRUG

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.

IV midazolam

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates requiring MR imaging for diagnosis

You may not qualify if:

• Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations

Sponsors & Collaborators

• Baskent University: lead

MeSH Terms

Conditions

Epilepsy; Wounds and Injuries; Metabolic Diseases

Interventions

Glucose; Midazolam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anis Aribogan, Prof

  Baskent University Department of Anesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass Prof

Study Record Dates

• First Submitted: December 30, 2015
• First Posted: January 1, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 1, 2016

Record last verified: 2015-12