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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04730362
Other study ID # AP2007-50111
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date March 1, 2022

Study information

Verified date April 2022
Source National Cancer Institute, Egypt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study compare the effects of Oral airway vs LMA in preventing anesthesia-induced partial airway obstruction, in an attempt to lessen MRI motion artifacts, which would result in improvements in image quality.


Description:

Magnetic resonance image (MRI) is a frequently used imaging technique especially in oncological patients, where it is used for diagnosis, following up response to treatment and later for detection of possible recurrence. The main problem encountered with MRI is the long time required for completion of the imaging, during which the patient is required to lie still. Patients who are unable to lie still require sedation or general anesthesia (GA). Almost all pediatric patients are uncooperative, making GA, the standard of care for pediatric MRI. Several general anesthetic techniques including airway management by endotracheal tube & various supraglottic devices (LMA) have been described. Choice of technique by anesthesiologist is influenced by the patient's age, craniofacial and airway anatomy, procedure duration, & illness acuity.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility Inclusion Criteria: - ASA ? and II patients - Age under 18 years . - The patient will need GA and patient Scheduled for MRI brain. Exclusion Criteria: - Glasgow coma scale = 8 - Emergency patient with full stomach. - Distorted upper airway anatomy making intubation with GA mandatory.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
guedel airway
Anesthesia will be conducted by induction with 1-2 • Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%. The goal is to maintain the patient spontaneous ventilation throughout the procedure. Monitoring of the patients is done by MRI compatible pulse oximetry for heart rate and oxygen saturation which is connected to MRI control room.
supraglottic airway
supraglottic airway
Drug:
propofol bolus and then anesthesia sevoflurane
Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%

Locations

Country Name City State
Egypt Nataional Cancer Instituite Cairo

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Image quality of each MRI sequence Image quality of each MRI sequence is evaluated by using a scoring system with the following scores: score of 1 (non-diagnostic), score of 2 (poor quality but some diagnostic value), score of 3 (average), score of 4 (good), and score of 5 (excellent). During general anesthesia of MRI investigation procedure
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