Comparison of Gastric Insufflation Volume Between LarySeal Pro and Ambu AuraGain Using Ultrasonography In Pediatric Patients Undergoing General Anesthesia With Controlled Ventilation. A Randomized Controlled Trial.
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Objectives: To assess and compare gastric insufflation volume between LarySeal Pro laryngeal mask and Ambu AuraGain laryngeal mask in pediatric patients using pelviabdominal ultrasound undergoing general anesthesia. Hypothesis We hypothesize that LarySeal Pro laryngeal mask produce gastric insufflation volume less than Ambu AuraGain laryngeal mask in pediatric patients undergoing general anesthesia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 10
Healthy Volunteers: t
View:
• • Age: pediatrics (6-12years )
‣ Patients with a Mallampati score of I - II
⁃ Elective surgeries
⁃ Short procedure expected to last for 1 hour or less .
⁃ ASA I - II
Locations
Other Locations
Egypt
Cairo Universty
RECRUITING
Cairo
Contact Information
Primary
dr mahmoud abdeltawab gbre, lectrer MD
mahmoud15588@gmail.com
+020109772251
Backup
dr sherif soida, assistant proffesour
+02 01223663504
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 106
Treatments
Active_comparator: Ambu AuraGain
Before induction of anesthesia, a gastric antrum ultrasound will be performed to assess gastric air volume by measuring the cross-sectional area of the gastric antrum in a supine position. The measurements will be taken between antral contractions to provide an accurate baseline value.In operation room, routine monitoring is established before induction of anesthesia . Group B receiving the Ambu AuraGain.Induction of general anesthesia will be achieved by inhalation induction by sevoflurane then securing IV access by proper sized cannula then all patients will received Fentanyl 1ug/kg, Propofol 2mg/kg and,tracium 0.5mg/kg. Mechanical ventilation will be employed be kept below \<15 (cmH2O) to avoid gastric insufflation.Postinsertion gastric (CSA) in the supine position will be measured using ultrasound after laryseal pro insertion and before removal.Then record readings pre and postop insertion then compare between 2 devices regarding gastric antral volume.
Active_comparator: Larysealpro
: Before induction of anesthesia, a gastric antrum ultrasound will be performed to assess gastric air volume by measuring the cross-sectional area of the gastric antrum in a supine position. The measurements will be taken between antral contractions to provide an accurate baseline value.In operation room, routine monitoring is established before induction of anesthesia . Either Group A, receiving the LarySeal Pro laryngeal mask Induction of general anesthesia will be achieved by inhalation induction by sevoflurane then securing IV access by proper sized cannula then all patients will received Fentanyl 1ug/kg, Propofol 2mg/kg and,tracium 0.5mg/kg. Mechanical ventilation will be employed be kept below \<15 (cmH2O) to avoid gastric insufflation.Postinsertion gastric (CSA) in the supine position will be measured using ultrasound after laryseal pro insertion. Then record readings pre and post insertion and post operative then compare between 2 devices regarding gastric antral volume
Related Therapeutic Areas
Sponsors
Leads: Cairo University