Clinical trial NCT06656455: Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask for EUA in Children
Official title: Comparison of Two Anesthetic Protocols (Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask) for Eye Examination Under Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Children, Only
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to discharge from the operating room
timeFrame: Time from the end of surgery to discharge from OR, assessed up to 40 minutes
Secondary outcomes:
measure: Duration of anesthesia
timeFrame: From the start till the end of anesthesia, assessed up to 120 minutes
measure: Duration of surgical procedure
timeFrame: From the start of eye examination till the completion of the procedure, assessed up to 60 minutes
measure: Ophthalmologist satisfaction score
timeFrame: During the procedure
measure: Apnea
timeFrame: During the procedure
measure: Desaturation
timeFrame: During the procedure
measure: Laryngospasm
timeFrame: During the procedure
measure: Interruption
timeFrame: During the procedure
measure: Emergence agitation
timeFrame: Immediately after the procedure
measure: Wake up time
timeFrame: Time from the end of anesthesia drug administration to spontaneous eye opening, assessed up to 180 minutes
measure: PACU stay duration
timeFrame: Time from arrival to PACU till achievement of an Aldrete score of 9, assessed up to 180 minutes
measure: Change in the airway management
timeFrame: Number of participants with change in airway management assessed by the data collector during the procedure
measure: Emesis
timeFrame: Number of participants who developed emesis, assessed by the data collector immediately after the procedure
measure: Administration of pain medication
timeFrame: Number of participants who were administered pain medication, assessed by the data collector immediately after the procedure
measure: Airway Obstruction
timeFrame: Number of participants who had an airway obstruction, assessed by the data collector during the procedure
measure: Hypoventilation
timeFrame: Number of participants who developed hypoventilation, assessed by the data collector during the procedure
measure: Excess secretions
timeFrame: Number of participants who developed excess secretions, assessed by the data collector during the procedure
measure: Induction time
timeFrame: Time from anesthesia start to surgery start, assessed up to 60 minutes
measure: Nonoperative time
timeFrame: Time from anesthesia start to surgery start combined with the time to discharge from OR, assessed up to 60 minutes
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Cynthia Karam, MD
role: PRINCIPAL_INVESTIGATOR
References: