Muscle Relaxation for Pediatric Adenotonsillectomy
Completed · Phase 4
Conditions studied: Tonsillectomy
In brief
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.
Key facts
- Study ID
- NCT06225466
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 172
- Starts
- 2024-04-10
- Expected to finish
- 2024-09-27
- Last updated by the study team
- 2025-07-28
Who can join
Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Children's Health Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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