Muscle Relaxation for Pediatric Adenotonsillectomy

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Tonsillectomy

Treatments: Drug: Rocuronium; Other: Anesthesia without neuromuscular blockade; Drug: Sugammadex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06225466

STU2023-0851

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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172 participants in 2 patient groups

Neuromuscular blockade

Active Comparator group

Description:

Rocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery. SOC drugs: Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. Sevoflurane induction and maintenance of anesthesia Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses). Ondansetron 0.1 mg/kg (max 4 mg) IV intraop Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours. Device monitoring: Bispectral index system intraop TetraGraph neuromuscular transmission monitor intraop ExSpiron respiratory volume monitor intraop and in PACU

Treatment:

Drug: Sugammadex

Drug: Rocuronium

No neuromuscular blockade

Other group

Description:

Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered. SOC drugs: Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. Sevoflurane induction and maintenance of anesthesia Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses). Ondansetron 0.1 mg/kg (max 4 mg) IV intraop Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours. Device monitoring: Bispectral index system intraop ExSpiron respiratory volume monitor intraop and in PACU

Treatment:

Other: Anesthesia without neuromuscular blockade