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NCT06225466 · ClinicalTrials.gov registry record · Phase 4
Muscle Relaxation for Pediatric Adenotonsillectomy
A Phase 4 study of Tonsillectomy, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 172
- Enrollment target
- 1
- Study location
NCT06225466: Completed Phase 4 study of Tonsillectomy, sponsored by University of Texas Southwestern Medical Center.
NCT06225466 is a Phase 4 study of Tonsillectomy that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 172 participants, below the 1,764-participant average among 6 other Tonsillectomy trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06225466, a Phase 4 study of Tonsillectomy, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 172 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Continuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight
Conditions Studied
Interventions
- DRUG Rocuronium
- DRUG Sugammadex
- OTHER Anesthesia without neuromuscular blockade
Study Locations (1)
Texas
- Children's Health Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2024-04-10 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 4 |
What the finished NCT06225466 record still lists
NCT06225466 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 1,764-participant average among 6 other Tonsillectomy trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Tonsillectomy appearing as the primary indexed condition, and to 3 interventions - of which Rocuronium is the first listed.
NCT06225466 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06225466 about?
NCT06225466 is a clinical study titled "Muscle Relaxation for Pediatric Adenotonsillectomy". 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 gener...
What is the current status of trial NCT06225466?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 172 participants. The study started on 2024-04-10. Estimated completion is 2024-09-27.
What conditions does trial NCT06225466 study?
This clinical trial studies the following conditions: Tonsillectomy.
What interventions are being tested in trial NCT06225466?
The interventions under investigation include: Rocuronium (DRUG), Sugammadex (DRUG), Anesthesia without neuromuscular blockade (OTHER).
Who is sponsoring clinical trial NCT06225466?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06225466 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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