An interventional study of sevoflurane via LMA and Propofol with oxygen via simple mask in Anesthesia and Children, Only, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to participants aged 1 Year to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by American University of Beirut Medical Center · Not applicable, Interventional, and Treatment
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.
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.
American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 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%.
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.
Time to discharge from the operating room
Time to discharge from the operating room in minutes
Time frame: Time from the end of surgery to discharge from OR, assessed up to 40 minutes
Duration of anesthesia
Duration of anesthesia in minutes
Time frame: From the start till the end of anesthesia, assessed up to 120 minutes
Duration of surgical procedure
Duration of surgical procedure in minutes
Time frame: 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).
Time frame: During the procedure
Apnea
Apnea \>10 seconds
Time frame: During the procedure
Desaturation
SPO2\<94%
Time frame: During the procedure
Laryngospasm
Laryngospasm requiring treatment
Time frame: During the procedure
Interruption
Number of interruptions of EUA
Time frame: During the procedure
Emergence agitation
Emergence agitation on a four-point scale
Time frame: Immediately after the procedure
Wake up time
Wake up time in minutes
Time frame: 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 frame: 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
Time frame: Number of participants with change in airway management assessed by the data collector during the procedure
Emesis
Emesis
Time frame: Number of participants who developed emesis, assessed by the data collector immediately after the procedure
Administration of pain medication
Administration of pain medication
Time frame: Number of participants who were administered pain medication, assessed by the data collector immediately after the procedure
Airway Obstruction
Airway Obstruction
Time frame: Number of participants who had an airway obstruction, assessed by the data collector during the procedure
Hypoventilation
Hypoventilation
Time frame: Number of participants who developed hypoventilation, assessed by the data collector during the procedure
Excess secretions
Excess secretions
Time frame: Number of participants who developed excess secretions, assessed by the data collector during the procedure
Induction time
Induction time in minutes
Time frame: Time from anesthesia start to surgery start, assessed up to 60 minutes
Nonoperative time
Nonoperative time in minutes
Time frame: Time from anesthesia start to surgery start combined with the time to discharge from OR, assessed up to 60 minutes
Plan to share: No
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American University of Beirut Medical Center