Clinical Trials Logo

Clinical Trial Summary

Sedation is required in infants and children to successfully complete MRI while maintaining respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk during MRI examination. Therefore, appropriate drugs need to be selected, administered, and titrated to achieve these objectives. Propofol is commonly used for sedation in children in the MRI setting because of its predictability, rapid onset, and offset of action. Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and respiratory stability. The rationale of this research is to assess the effect of these drugs on the upper airway and validate their use in children with upper airway disorders.


Clinical Trial Description

Objectives The objective of this study is to compare the changes in upper airway configuration at the level of soft palate, base of tongue and tip of the epiglottis in children sedated with dexmedetomidine and propofol in children undergoing MRI.

We hypothesize that the upper airway caliber will be smaller in children receiving propofol than with dexmedetomidine.

Primary Outcome To measure the cross-sectional area (CSA) of the upper airway at the level of soft palate, base of the tongue and epiglottis in both groups of children at high doses of propofol and dexmedetomidine and thus compare the decrease in CSA with increasing doses of both drugs.

Secondary Outcomes To measure the

- anteroposterior (AP) diameter

- transverse (Tr) diameter of the upper airway at the three levels in both groups of children at both low and high doses of propofol and dexmedetomidine and compare the decrease in AP and Tr diameter at increasing doses of dexmedetomidine. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01505933
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Terminated
Phase Phase 2
Start date February 2012
Completion date April 30, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05573919 - VivAer: A Correlation Between Symptom Scores and Objective Findings N/A
Recruiting NCT03842839 - Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography N/A
Completed NCT04765761 - Proseal Laryngeal Mask Airway With or Without Introducer-tool Stabilization for Pressure Controlled Ventilation N/A
Recruiting NCT06288516 - BenRalizumab Effect on Airway Remodeling in Severe asTHma Phase 4
Enrolling by invitation NCT05692362 - Measure Airway Compliance by Endobronchial Optical Coherence Tomography
Completed NCT02566291 - Observational Study With Investigation of Two Second Generation Laryngeal Masks N/A
Completed NCT01178229 - Physiotherapy on the Airway of Bruxist Children Phase 1/Phase 2
Completed NCT06236971 - Effect of Lateral Positions on the Shape of Upper Airway
Recruiting NCT05550402 - Role of Parasympathetic Activity in Mild to Severe Asthma With Fixed Airway Obstruction (PARASMA Study) N/A