Airway Complications After LMA in Children

NCT ID: NCT03553082

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-18
• Study Completion Date: 2021-05-28

Brief 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. 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.

Conditions

Anesthesia Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Total intravenous anesthsia

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance

Sevoflurane

Patients in this group will receive sevoflurane 8% and fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance.

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance

Interventions

Sevoflurane

Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance

Intervention Type: DRUG

Propofol

Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: 6 months to 6 years old

2. Patients undergoing short duration procedure ( ˂ 2 hours) (such as polysite removal, closed reduction, eye examination, excluding thoracic and abdominal surgery)

3. American Society of Anesthesiologists (ASA): I-III

4. Patients undergoing LMA general anesthesia. (NPO, short procedures, patient without known airway abnormalities).

5. Parental consent

Exclusion Criteria

1. Age: more than 6 years old and less than 6 months

2. Patients having: Asthma, hyper reactive airway (Acute exacerbation)

3. Patients having recent respiratory tract infection within 2 weeks.

4. Patients with congenital heart disease

5. 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)

6. Patients at high risk of aspiration

7. Anticipated difficult airway

8. Patient with neurologic disorders (children with known neurologic disorders: seizure, mental retardation, cerebral palsy)

9. Difficult LMA insertion (> 3 attempts)

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jean berezian

Instructor of clinical Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

American University of Beirut

Beirut, , Lebanon

Countries

Lebanon

References

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.

Reference Type: DERIVED

PMID: 35213484 (View on PubMed)

Other Identifiers

BIO-2017-0276

Identifier Type: -

Identifier Source: org_study_id