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

Summary

The goal of this clinical trial is to find out the optimal technique of anesthesia for eye examination in children. The main question it aims to answer is:

Is propofol infusion and simple oxygen facemask associated with earlier discharge from the operating room, and hence rapid turnover and greater efficiency compared to sevoflurane via LMA? Researchers will compare time to discharge from the operating room to see if eye examination for children less than 7 years using a propofol infusion pump based anesthesia and simple oxygen facemask results in a shorter discharge time from the operating room in comparison with sevoflurane via LMA.

Participants will will be assigned to receive general anesthesia by one of two treatment groups.

Conditions

• Anesthesia
• Children, 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.

Sponsors & Collaborators

• American University of Beirut Medical Center

  lead OTHER

Principal Investigators

• Cynthia Karam, MD · American University of Beirut Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-23

Primary Completion

2024-07-08

Completion

2024-07-08

Countries

• Lebanon

Study Locations