AnesthesiaNCT06656455
Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask for EUA in Children
A study testing sevoflurane via LMA and Propofol with oxygen via simple mask in people with Anesthesia and Children, Only, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Children, Only
- What is being tested?
- sevoflurane via LMA and Propofol with oxygen via simple mask
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 23 May 2017to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Children, Only
- Being tested
- sevoflurane via LMA, Propofol with oxygen via simple mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevoflurane via LMADrug
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%.
Propofol with oxygen via simple maskDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Propofol with oxygen via simple mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge from the operating room
Time to discharge from the operating room in minutes
Measured: Time from the end of surgery to discharge from OR, assessed up to 40 minutes
Secondary outcomes (18)
Duration of anesthesia
Duration of anesthesia in minutes
Measured: From the start till the end of anesthesia, assessed up to 120 minutes
Duration of surgical procedure
Duration of surgical procedure in minutes
Measured: 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).
Measured: During the procedure
Apnea
Apnea >10 seconds
Measured: During the procedure
Desaturation
SPO2<94%
Measured: During the procedure
Laryngospasm
Laryngospasm requiring treatment
Measured: During the procedure
Interruption
Number of interruptions of EUA
Measured: During the procedure
Emergence agitation
Emergence agitation on a four-point scale
Measured: Immediately after the procedure
Wake up time
Wake up time in minutes
Measured: 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
Measured: 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
Measured: Number of participants with change in airway management assessed by the data collector during the procedure
Emesis
Emesis
Measured: Number of participants who developed emesis, assessed by the data collector immediately after the procedure
Administration of pain medication
Administration of pain medication
Measured: Number of participants who were administered pain medication, assessed by the data collector immediately after the procedure
Airway Obstruction
Airway Obstruction
Measured: Number of participants who had an airway obstruction, assessed by the data collector during the procedure
Hypoventilation
Hypoventilation
Measured: Number of participants who developed hypoventilation, assessed by the data collector during the procedure
Excess secretions
Excess secretions
Measured: Number of participants who developed excess secretions, assessed by the data collector during the procedure
Induction time
Induction time in minutes
Measured: Time from anesthesia start to surgery start, assessed up to 60 minutes
Nonoperative time
Nonoperative time in minutes
Measured: Time from anesthesia start to surgery start combined with the time to discharge from OR, assessed up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start23 May 2017
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia Karam, American University of Beirut Medical Center
- Investigators
- Cynthia Karam, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656455
- Sponsor's protocol ID
- ANES.CK.01
- Status last verified
- May 2025
- First submitted
- 21 Oct 2024
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Anesthetic Protocols (Sevoflurane and Laryngeal Mask Airway Versus Propofol Infusion and Facemask) for Eye Examination Under Anesthesia in Children
- ClinicalTrials.gov ID
- NCT06656455
- Acronym / sponsor ID
- ANES.CK.01
- Conditions
- Anesthesia, Children, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 23 May 2017 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Active comparator | Drug: sevoflurane via LMAGroup S will be given propofol 2 mg/kg and fentanyl 1µg/kg intravenously and anesthesia will be maintained with sevoflurane via LMA |
| Group P | Experimental | Drug: Propofol with oxygen via simple maskPatients 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. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sevoflurane via LMAIn 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 | Group S |
| Propofol with oxygen via simple maskIn 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. | Drug | Group P |
Primary outcome
Time to discharge from the operating room
Time frame: Time from the end of surgery to discharge from OR, assessed up to 40 minutes
Time to discharge from the operating room in minutes
18 secondary outcomes
Duration of anesthesia
Time frame: From the start till the end of anesthesia, assessed up to 120 minutes
Duration of surgical procedure
Time frame: From the start of eye examination till the completion of the procedure, assessed up to 60 minutes
Ophthalmologist satisfaction score
Time frame: During the procedure
Apnea
Time frame: During the procedure
Desaturation
Time frame: During the procedure
Laryngospasm
Time frame: During the procedure
Interruption
Time frame: During the procedure
Emergence agitation
Time frame: Immediately after the procedure
Wake up time
Time frame: Time from the end of anesthesia drug administration to spontaneous eye opening, assessed up to 180 minutes
PACU stay duration
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
Time frame: Number of participants with change in airway management assessed by the data collector during the procedure
Emesis
Time frame: Number of participants who developed emesis, assessed by the data collector immediately after the procedure
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
Time frame: Number of participants who had an airway obstruction, assessed by the data collector during the procedure
Hypoventilation
Time frame: Number of participants who developed hypoventilation, assessed by the data collector during the procedure
Excess secretions
Time frame: Number of participants who developed excess secretions, assessed by the data collector during the procedure
Induction time
Time frame: Time from anesthesia start to surgery start, assessed up to 60 minutes
Nonoperative time
Time frame: Time from anesthesia start to surgery start combined with the time to discharge from OR, assessed up to 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Karam, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sevoflurane via LMA and Propofol with oxygen via simple mask in people with Anesthesia and Children, Only, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to discharge from the operating room (time frame: Time from the end of surgery to discharge from OR, assessed up to 40 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.