Anesthesia RecoveryNCT03553082
Airway Complications After LMA in Children
A study testing Sevoflurane and Propofol in people with Anesthesia Recovery, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Background: The removal of Laryngeal Mask Airway (LMA) in children may be associated with respiratory adverse events. The incidence of these adverse events may be influenced by the type of anesthesia maintenance. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Anesthesia Recovery
- What is being tested?
- Sevoflurane and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteLebanon
- Study dates
- 18 May 2018to 28 May 2021
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6 months to 6 years old
- Patients undergoing short duration procedure ( ˂ 2 hours) (such as polysite removal, closed reduction, eye examination, excluding thoracic and abdominal surgery)
- American Society of Anesthesiologists (ASA): I-III
- Patients undergoing LMA general anesthesia. (NPO, short procedures, patient without known airway abnormalities).
- Parental consent
Who cannot join
- Age: more than 6 years old and less than 6 months
- Patients having: Asthma, hyper reactive airway (Acute exacerbation)
- Patients having recent respiratory tract infection within 2 weeks.
- Patients with congenital heart disease
- Patients not eligible for LMA (full stomach, hiatal hernia, known or predicted difficult airway, syndromic patient with facial or airway malformation, patient undergoing major abdominal or thoracic surgery)
- Patients at high risk of aspiration
Show all 9Show fewer
- Anticipated difficult airway
- Patient with neurologic disorders (children with known neurologic disorders: seizure, mental retardation, cerebral palsy)
- Difficult LMA insertion (> 3 attempts)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Frequency of Airway Complications After LMA Removal in Children: A Comparison of TIVA and Sevoflurane
Background: The removal of Laryngeal Mask Airway (LMA) in children may be associated with respiratory adverse events. The incidence of these adverse events may be influenced by the type of anesthesia maintenance. It is not clear whether Total Intravenous Anesthesia (TIVA) with propofol is associated with a lower incidence of respiratory events upon removal of LMA as compared to maintenance with sevoflurane.
Specific Aim: The primary aim of this study is to compare the prevalence of respiratory adverse events following LMA removal in patient receiving TIVA versus sevoflurane inhalational anesthesia in a pediatric population aged between 6 month and 6 years old. Secondary outcomes include quality of induction, maintenance and emergence from anesthesia between the 2 groups as evidenced by ease of LMA insertion, absence of bucking or movement during the procedure, time to LMA removal, and absence of emergence agitation.
Read more
Methods: In this prospective randomized clinical trial, children will be enrolled in one of two groups: Group 1 will receive propofol for induction and maintenance of anesthesia, Group 2 will receive sevoflurane for induction and maintenance of anesthesia. In both groups patients will be mechanically ventilated. At the end of the procedure, LMAs will be removed when patients are fully awake as defined by the return of reflexes, eye opening, and purposeful movements.
Significance: Data comparing the influence of TIVA and sevoflurane on the occurrence of respiratory adverse events after LMA removal are limited. Both techniques are standard of care at our institution. However, as per our clinical observations, we hypothesize that TIVA is superior to sevoflurane. This study will identify the technique that provides optimal anesthetic conditions and improved patient's safety.
- Conditions
- Anesthesia Recovery
- Being tested
- Sevoflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance
PropofolDrug
Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthsia | Active comparator | Patients in this group will receive Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance. Receives: Drug: Propofol |
| Sevoflurane | Active comparator | Patients in this group will receive sevoflurane 8% and fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory adverse outcomes
Encountered respiratory adverse outcomes such as cough
Measured: 2 hours
Secondary outcomes (4)
Time to emergence
Emergence time defined as the time from discontinuation of the anesthetic agents until LMA removal.
Measured: 2 hours
LMA insertion characteristics
Number of attempts and time taken to insertion, as well as adverse events encountered during insertion.
Measured: 2 hours
Quality of anesthesia
Lack of movement, bucking, cough
Measured: 2 hours
Emergence agitation
4 points scale: 1: calm, 2: not calm but easily consolable, 3: not easily calmed restless or moderately agitated, 4: combative, disoriented or excited.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start18 May 2018
- Primary completion28 May 2021
- Study completion28 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia RecoveryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean berezian, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553082
- Sponsor's protocol ID
- BIO-2017-0276
- Status last verified
- Aug 2021
- First submitted
- 8 May 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karam C, Zeeni C, Yazbeck-Karam V, Shebbo FM, Khalili A, Abi Raad SG, Beresian J, Aouad MT, Kaddoum R. Respiratory Adverse Events After LMA(R) Mask Removal in Children: A Randomized Trial Comparing Propofol to Sevoflurane. Anesth Analg. 2023 Jan 1;136(1):25-33. doi: 10.1213/ANE.0000000000005945. Epub 2022 Feb 25.
PubMed 35213484
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency of Airway Complications After LMA Removal in Children: A Comparison of TIVA and Sevoflurane
- ClinicalTrials.gov ID
- NCT03553082
- Acronym / sponsor ID
- BIO-2017-0276
- Conditions
- Anesthesia Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 18 May 2018 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 28 May 2021 (actual)
- First posted
- 12 Jun 2018 (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.
Background: The removal of Laryngeal Mask Airway (LMA) in children may be associated with respiratory adverse events. The incidence of these adverse events may be influenced by the type of anesthesia maintenance. It is not clear whether Total Intravenous Anesthesia (TIVA) with propofol is associated with a lower incidence of respiratory events upon removal of LMA as compared to maintenance with sevoflurane.
Specific Aim: The primary aim of this study is to compare the prevalence of respiratory adverse events following LMA removal in patient receiving TIVA versus sevoflurane inhalational anesthesia in a pediatric population aged between 6 month and 6 years old. Secondary outcomes include quality of induction, maintenance and emergence from anesthesia between the 2 groups as evidenced by ease of LMA insertion, absence of bucking or movement during the procedure, time to LMA removal, and absence of emergence agitation.
Methods: In this prospective randomized clinical trial, children will be enrolled in one of two groups: Group 1 will receive propofol for induction and maintenance of anesthesia, Group 2 will receive sevoflurane for induction and maintenance of anesthesia. In both groups patients will be mechanically ventilated. At the end of the procedure, LMAs will be removed when patients are fully awake as defined by the return of reflexes, eye opening, and purposeful movements.
Significance: Data comparing the influence of TIVA and sevoflurane on the occurrence of respiratory adverse events after LMA removal are limited. Both techniques are standard of care at our institution. However, as per our clinical observations, we hypothesize that TIVA is superior to sevoflurane. This study will identify the technique that provides optimal anesthetic conditions and improved patient's safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthsia | Active comparator | Drug: PropofolPatients in this group will receive Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance. |
| Sevoflurane | Active comparator | Drug: SevofluranePatients in this group will receive sevoflurane 8% and fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age: 6 months to 6 years old
- Patients undergoing short duration procedure ( ˂ 2 hours) (such as polysite removal, closed reduction, eye examination, excluding thoracic and abdominal surgery)
- American Society of Anesthesiologists (ASA): I-III
- Patients undergoing LMA general anesthesia. (NPO, short procedures, patient without known airway abnormalities).
- Parental consent
Key exclusion criteria (9 listed)
- Age: more than 6 years old and less than 6 months
- Patients having: Asthma, hyper reactive airway (Acute exacerbation)
- Patients having recent respiratory tract infection within 2 weeks.
- Patients with congenital heart disease
- Patients not eligible for LMA (full stomach, hiatal hernia, known or predicted difficult airway, syndromic patient with facial or airway malformation, patient undergoing major abdominal or thoracic surgery)
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 |
|---|---|---|
| SevofluraneFentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance | Drug | Sevoflurane |
| PropofolPropofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance | Drug | Total intravenous anesthsia |
Primary outcome
Respiratory adverse outcomes
Time frame: 2 hours
Encountered respiratory adverse outcomes such as cough
4 secondary outcomes
Time to emergence
Time frame: 2 hours
LMA insertion characteristics
Time frame: 2 hours
Quality of anesthesia
Time frame: 2 hours
Emergence agitation
Time frame: 2 hours
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 24 Aug 2021.
- Derived from this study: PubMed 35213484Karam C, Zeeni C, Yazbeck-Karam V, Shebbo FM, Khalili A, Abi Raad SG, Beresian J, Aouad MT, Kaddoum R. Respiratory Adverse Events After LMA(R) Mask Removal in Children: A Randomized Trial Comparing Propofol to Sevoflurane. Anesth Analg. 2023 Jan 1;136(1):25-33. doi: 10.1213/ANE.0000000000005945. Epub 2022 Feb 25.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Propofol in people with Anesthesia Recovery, 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 5 inclusion and 9 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 24 Aug 2021. 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?
Respiratory adverse outcomes (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553082, which also lists 1 linked publication.
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 24 Aug 2021.