Phase 4 N=172 Randomized Triple-blind Prevention

Muscle Relaxation for Pediatric Adenotonsillectomy

Tonsillectomy

Bottom Line

View on ClinicalTrials.gov: NCT06225466 ↗

Enrolled (actual)

172

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Cumulative Intra- and Postoperative Opioid Consumption — 0.209; 0.188 IV morphine milligram equivalent/kg — p=0.123

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Rocuronium (Drug); Sugammadex (Drug); Anesthesia without neuromuscular blockade (Other)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Sep 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Cumulative Intra- and Postoperative Opioid Consumption	0.209; 0.188	0.123
SECONDARY Number of Participants With Postoperative Respiratory Events	32; 38; 31; 37; 4; 10	0.102
SECONDARY Number of Low Minute Ventilation (MV) Events in the Post-anesthesia Care Unit	0; 0	0.008 sig

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.

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 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

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Data sourced from ClinicalTrials.gov (NCT06225466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.