Clinical trial NCT06225466: Muscle Relaxation for Pediatric Adenotonsillectomy
Official title: Anesthesia With Neuromuscular Blockade and Reversal With Sugammadex Compared to Anesthesia Without Muscle Relaxation During Pediatric High-Risk Adenotonsillectomy: A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tonsillectomy
Keywords: Sleep Apnea, Obstructive
Child
Snoring
Sleep Apnea Syndromes
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2024-01-26
Enrollment: 172
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, patient- and assessor-blinded, parallel arm, controlled trial
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to compare general anesthesia with muscle relaxation and reversal of the relaxation at the end of surgery or without muscle relaxation in high-risk children having adenotonsillectomy surgery. The main questions it aims to answer are:

1. What is the impact of general anesthesia with muscle relaxation on opioid pain medication requirements during and after adenotonsillectomy?
2. What is the impact of general anesthesia with muscle relaxation on postoperative breathing complications and the adequacy of postoperative lung air volumes during breathing?

Participants will wear three additional, noninvasive monitors during surgery, and one additional monitor after surgery. The amount of opioid pain medication required will be tracked, and the patient will be observed postoperatively for breathing complications. Measurements will be collected from the monitor worn postoperatively.

Researchers will compare general anesthesia with muscle relaxation and reversal of relaxation at the end of surgery with general anesthesia without muscle relaxation to test the hypothesis that the approach using muscle relaxation reduces the amount of opioid pain medication required during and after surgery.

Detailed description: This will be a randomized, patient- and assessor-blinded, parallel arm, controlled trial assessing the efficacy of neuromuscular blockade with reversal during the anesthetic management of pediatric adenotonsillectomy (AT) to reduce intra- and postoperative opioid consumption and postoperative respiratory events in high-risk patients. Enrolled participants will be randomized by computer-generated assignment using stratified blocked randomization with a 1:1 allocation into 2 arms: neuromuscular blockade with reversal at the end of surgery and no neuromuscular blockade. Randomization will occur on the following strata: severe versus non-severe obstructive sleep apnea (OSA)/sleep disordered breathing. Patients/families, treating teams (except for the anesthesia team), and research staff/investigators responsible for measuring and adjudicating outcomes will be blinded to allocation.

Primary Efficacy Objective - Evaluate intraoperative and postoperative opioid consumption in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex.

Secondary Objectives - (1) Evaluate postoperative respiratory events in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex. The outcome of postoperative respiratory events will be a composite measure consisting of 1) airway obstruction or hypoxemia, defined as SpO2 less than 90 percent, requiring any of the following interventions: supplemental oxygen by nasal cannula or simple face mask, noninvasive positive airway pressure, or reintubation; or 2) unanticipated intensive care unit (ICU) admission. (2) Evaluate postoperative low minute ventilation (MV) episodes, defined as MV less than 40 percent predicted for at least 2 minutes and measured by a respiratory volume monitor (RVM), in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex.

Eligibility criteria: Inclusion Criteria:

* Children 2-12 years of age having tonsillectomy with or without adenoidectomy at Children's main Dallas campus
* Considered high-risk\* with pre-planned overnight admission after surgery for respiratory monitoring \*High-risk children have any one of the following characteristics: age \< 3 years, severe obstructive sleep apnea (apnea-hypopnea index \> 10 events per hour), or obesity (body mass index \> 98th percentile).

Exclusion Criteria:

* Planned placement on positive airway pressure or supplemental oxygen postoperatively
* Secondary procedures under the same anesthetic, except for myringotomy tubes or auditory brainstem response testing
* Children with neuromuscular disorders such as congenital myopathies, myotonias, or myasthenia gravis
* Known rocuronium, vecuronium, or sugammadex allergy

Primary outcomes:
measure: Cumulative intra- and postoperative opioid consumption
timeFrame: From surgery start to discharge home, up to 24 hours
Secondary outcomes:
measure: Number of participants with postoperative respiratory events
timeFrame: From post-anesthesia care unit admission to discharge home, up to 24 hours
measure: Number of low minute ventilation (MV) events in the post-anesthesia care unit
timeFrame: From post-anesthesia care unit admission to transfer to the postoperative ward, up to 8 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Health Dallas
state: Texas
Study officials:
affiliation: UT Southwestern
name: Proshad Efune, MD
role: PRINCIPAL_INVESTIGATOR
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