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

Comparison of Two Anesthetic Protocols (Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask) for Eye Examination Under Anesthesia in Children

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Children, Only
• Intervention / Treatment: Drug: sevoflurane via LMA; Drug: Propofol with oxygen via simple mask

Detailed Description

Children younger than 5 years can be uncooperative during an examination and may render it impossible. The main objective of anesthesia for ophthalmic examination is to provide ideal conditions for optimal exam with a quick onset and offset of anesthesia as well as rapid recovery and early discharge. Two commonly used sedation techniques for young children are: sevoflurane via laryngeal mask airway (LMA) or propofol infused intravenously. Both have been shown to be safe and effective and allow rapid changes in anesthesia depth and minimal postoperative morbidity. However, their induction, emergence characteristics, and side effect profiles may differ. From previous studies, it is still not evident whether propofol infusion using oxygen facemask or sevoflurane administration via LMA is superior with respect to earlier discharge from operating room in children undergoing eye examination under anesthesia (EUA).

In the literature, there are no studies directly comparing those two different techniques for ophthalmic examination.

The aim of this study is to find out the optimal technique of anesthesia for eye examination in children resulting in earlier discharge from the operating room thus decreasing the turnover time between cases and providing optimal surgical conditions, without interfering with the well-being of the child or compromising the airway security.

In a prospective randomized study, a total sample of 60 children scheduled for eye examination under anesthesia (30 in each arm of the study) aged between 1-7 years with American Society of Anesthesiologists physical status 1 to 3 will be assigned to receive general anesthesia by one of two treatment groups. After induction with sevoflurane 8% in oxygen, patients randomized to group S will be given propofol 2 mg/kg and fentanyl 1µg/kg intravenously and anesthesia will be maintained with sevoflurane via LMA. 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. In both groups sevoflurane concentration or propofol infusion will be titrated to keep optimal conditions. The primary outcome is time to discharge from the operating room. Secondary outcomes are surgical conditions, respiratory events, agitation and other side effects as well as recovery times. Normally distributed data will be summarized as mean ± SD and nonnormally distributed data will be summarized as median [interquartile range].

It is believed that propofol infusion and simple oxygen facemask will be associated with earlier discharge from the operating room, and hence rapid turnover and greater efficiency compared to sevoflurane via LMA. This study would have an impact on the current practice for pediatric ophthalmic EUA and may help find out the best technique that decreases the turnover time between cases resulting in higher operating time efficiency while providing optimal surgical conditions and patients' safety.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group S; 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; 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%.
Experimental: Group P; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of anesthesia	Duration of anesthesia in minutes	From the start till the end of anesthesia, assessed up to 120 minutes
Duration of surgical procedure	Duration of surgical procedure in minutes	From the start of eye examination till the completion of the procedure, assessed up to 60 minutes
Ophthalmologist satisfaction score	Ophthalmologist satisfaction score measured on likert scale (ranging from 1 till 5 with 1 representing the least degree of satisfaction and 5 the highest).	During the procedure
Apnea	Apnea >10 seconds	During the procedure
Desaturation	SPO2<94%	During the procedure
Laryngospasm	Laryngospasm requiring treatment	During the procedure
Interruption	Number of interruptions of EUA	During the procedure
Emergence agitation	Emergence agitation on a four-point scale	Immediately after the procedure
Wake up time	Wake up time in minutes	Time from the end of anesthesia drug administration to spontaneous eye opening, assessed up to 180 minutes
PACU stay duration	PACU stay duration in minutes	Time from arrival to PACU till achievement of an Aldrete score of 9, assessed up to 180 minutes
Change in the airway management	Change in the airway management	Number of participants with change in airway management assessed by the data collector during the procedure
Emesis	Emesis	Number of participants who developed emesis, assessed by the data collector immediately after the procedure
Administration of pain medication	Administration of pain medication	Number of participants who were administered pain medication, assessed by the data collector immediately after the procedure
Airway Obstruction	Airway Obstruction	Number of participants who had an airway obstruction, assessed by the data collector during the procedure
Hypoventilation	Hypoventilation	Number of participants who developed hypoventilation, assessed by the data collector during the procedure
Excess secretions	Excess secretions	Number of participants who developed excess secretions, assessed by the data collector during the procedure
Induction time	Induction time in minutes	Time from anesthesia start to surgery start, assessed up to 60 minutes
Nonoperative time	Nonoperative time in minutes	Time from anesthesia start to surgery start combined with the time to discharge from OR, assessed up to 60 minutes

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Cynthia Karam, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): July 8, 2024
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics, Inhalation; Sevoflurane; Propofol
• Other Study ID Numbers: ANES.CK.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No