Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask for EUA in Children

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 23, 2017

Primary Completion Date

July 8, 2024

Study Completion Date

July 8, 2024

Conditions
AnesthesiaChildren, Only
Interventions
DRUG

sevoflurane via LMA

In Group S, co-induction is used whereby the patient continues to receive 8% sevoflurane through the facemask followed after IV insertion by propofol 2mg/kg and fentanyl 1mic/kg administration. Thirty seconds afterwards, an age-appropriate LMA will be inserted. Sevoflurane is maintained initially at a concentration of 2%. The ventilation at first is assisted manually until the child starts breathing. If movement requires interruption of the exam, a bolus of propofol 1mg/kg is given and sevoflurane is increased by 1% until a maximal sevoflurane concentration of 4%. If apnea related to the depth of anesthesia occurs more than 10 sec or the saturation drops below 94%, sevoflurane will be turned off until the proper airway intervention is taken to achieve saturation above 95% and sevoflurane will be resumed at a concentration decreased by 1%.

DRUG

Propofol with oxygen via simple mask

"In group P, the sevoflurane will be discontinued, and propofol 1 mg/kg and fentanyl 1µg/kg will be administered IV. Propofol pump is maintained initially at a rate of 200mic/kg/min. with oxygen at 3 liters/min via facemask.~If movement requires interruption of the exam, a bolus of propofol 1mglkg is given and the infusion rate is increased by 20mic/kg/min up to a maximal rate of 350mic/kg/min. The total number of boluses needed will be recorded as the need for additional sedation. If apnea related to the depth of anesthesia occurs more than 10 sec or the saturation drops below 94%, the infusion pump will be stopped until the proper airway intervention is taken to achieve saturation above 95% with spontaneous breathing. Afterwards, the propofol pump will be resumed at a rate decreased by 20mic/kg/min."

Trial Locations (1)

Unknown

American University of Beirut Medical Center, Beirut

All Listed Sponsors
lead

American University of Beirut Medical Center

OTHER

NCT06656455 - Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask for EUA in Children | Biotech Hunter | Biotech Hunter