Muscle Relaxation for Pediatric Adenotonsillectomy

University of Texas Southwestern Medical Center172 enrolled

Overview

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.

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.

Interventions

RocuroniumDRUG

After induction of anesthesia and placement of an IV, rocuronium 0.6 mg/kg (maximum dose 50mg) will be administered. Additional doses of rocuronium 0.2 mg/kg (maximum dose 15 mg) will be administered when the neuromuscular transmission monitor indicates a train of four count of 2 or greater.

SugammadexDRUG

When the surgery is completed, sugammadex 2 mg/kg will be administered if the neuromuscular transmission monitor indicates the train of four count is 2 or greater. Sugammadex 4 mg/kg will be administered if 1) the train of four count is 1, or 2) if the train of four count is 0 and the post tetanic count is at least 1. There is no maximum dose of sugammadex.

Anesthesia without neuromuscular blockadeOTHER

Anesthesia without rocuronium or sugammadex

Eligibility

Sex: ALLMin age: 2 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cumulative Intra- and Postoperative Opioid Consumption

Continuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight

Time frame: From surgery start to discharge home, up to 24 hours

Secondary Outcomes

Number of Participants With Postoperative Respiratory Events

Composite binary outcome consisting of 1) airway obstruction or hypoxemia, defined as SpO2 \<90%, requiring any of the following interventions: supplemental oxygen by nasal cannula or simple face mask, noninvasive positive airway pressure, or reintubation; or 2) unanticipated ICU admission.

Time frame: From post-anesthesia care unit admission to discharge home, up to 24 hours

Number of Low Minute Ventilation (MV) Events in the Post-anesthesia Care Unit

Count outcome of distinct episodes of low MV. MV - the product of respiratory rate and tidal volume - was continuously measured by a noninvasive respiratory volume monitor. Low MV events were defined as episodes of MV less than 40 percent predicted - calculated by the monitor based on the patient's body surface area - for at least two minutes. This definition is routinely used by the monitoring system.

Time frame: From post-anesthesia care unit admission to transfer to the postoperative ward, up to 8 hours