Clinical trial
Anesthesia With Neuromuscular Blockade and Reversal With Sugammadex Compared to Anesthesia Without Muscle Relaxation During Pediatric High-Risk Adenotonsillectomy: A Randomized-Controlled Trial
Name
STU2023-0851
Description
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.
Trial arms
Trial start
2024-04-10
Estimated PCD
2025-05-01
Trial end
2025-08-01
Status
Recruiting
Phase
Early phase I
Treatment
Rocuronium
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.
Arms:
Neuromuscular blockade
Other names:
Neuromuscular blocking agent, Paralytic, Zemuron, Esmeron, Neuromuscular blocking drug, Nondepolarizing neuromuscular blocker, Nondepolarizing neuromuscular blocking agent, Nondepolarizing neuromuscular blocking drug
Sugammadex
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.
Arms:
Neuromuscular blockade
Other names:
Bridion, Neuromuscular blocking agent reversal, Neuromuscular blocking drug reversal, Paralytic reversal, Nondepolarizing neuromuscular blocking agent reversal, Nondepolarizing neuromuscular blocking drug reversal, Nondepolarizing neuromuscular blocker reversal
Anesthesia without neuromuscular blockade
Anesthesia without rocuronium or sugammadex
Arms:
No neuromuscular blockade
Size
172
Primary endpoint
Cumulative intra- and postoperative opioid consumption
From surgery start to discharge home, up to 24 hours
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 \< 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, patient- and assessor-blinded, parallel arm, controlled trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Patients/families, treating teams (except for the anesthesia team), and research staff/investigators responsible for measuring and adjudicating outcomes will be blinded to allocation.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 172, 'type': 'ESTIMATED'}}
Updated at
2024-04-12
1 organization
2 products
1 indication
Organization
University of Texas Southwestern Medical CenterProduct
RocuroniumIndication
TonsillectomyProduct
Sugammadex