Muscle Relaxation for Pediatric Adenotonsillectomy (NCT06225466) | Clinical Trial Compass
CompletedPhase 4
Muscle Relaxation for Pediatric Adenotonsillectomy
United States172 participantsStarted 2024-04-10
Plain-language 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.
Who can participate
Age range
2 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cumulative Intra- and Postoperative Opioid Consumption
Timeframe: From surgery start to discharge home, up to 24 hours
Trial details
NCT IDNCT06225466
SponsorUniversity of Texas Southwestern Medical Center