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

NCT06656455 | Completed

• 1 other identifier: ANES.CK.01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time to discharge from the operating room

  Time to discharge from the operating room in minutes

  Time from the end of surgery to discharge from OR, assessed up to 40 minutes

Secondary Outcomes (18)

• Duration of anesthesia

  From the start till the end of anesthesia, assessed up to 120 minutes

• Duration of surgical procedure

  From the start of eye examination till the completion of the procedure, assessed up to 60 minutes

• Ophthalmologist satisfaction score

  During the procedure

• Apnea

  During the procedure

• Desaturation

  During the procedure

Study Arms (2)

Group S

ACTIVE COMPARATOR

Group S will be given propofol 2 mg/kg and fentanyl 1µg/kg intravenously and anesthesia will be maintained with sevoflurane via LMA

Drug: sevoflurane via LMA

Group P

EXPERIMENTAL

Patients randomized to group P will be given propofol 1 mg/kg and fentanyl 1µg/kg intravenously and anesthesia will be maintained with a continuous infusion of propofol 200 µg/kg/min with oxygen 3 L/min via simple mask and oral airway if needed.

Drug: Propofol with oxygen via simple mask

Interventions

sevoflurane via LMA DRUG

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%.

Group S

Propofol with oxygen via simple mask DRUG

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.

Group P

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children presented to the Operating Room of the American University of Beirut Medical Center
• to 6 years old
• With American Society of Anesthesiologists physical status 1-3
• Scheduled for ophthalmic EUA with or without laser/cryotherapy procedure

You may not qualify if:

• Children with full stomach or significant aspiration risk (including hiatal hernia)
• Children who are morbidly obese or have a current upper respiratory tract infection
• Children who have oropharyngeal pathology (e.g., radiotherapy for hypopharynx/larynx), tracheostomies, or a family history of malignant hyperthermia
• Children of parents who refuse to give consent
• Children having allergy to the anesthetics used
• Any surgical procedure expected to last for more than 60 minutes

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Cynthia Karam, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 24, 2024
• Study Start: May 23, 2017
• Primary Completion: July 8, 2024
• Study Completion: July 8, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)