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TonsillectomyPhase 4NCT06225466

Muscle Relaxation for Pediatric Adenotonsillectomy

A Phase 4 study testing Rocuronium, Sugammadex and Anesthesia without neuromuscular blockade in people with Tonsillectomy, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 to 12 years
Conditions the study is for
Tonsillectomy
What is being tested?
Rocuronium, Sugammadex and Anesthesia without neuromuscular blockade
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteUnited States
Study dates
10 Apr 2024to 27 Sep 2024
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Health Dallas

    Dallas, Texas, 75235

Other trials in United States

About this study

Official title: Anesthesia With Neuromuscular Blockade and Reversal With Sugammadex Compared to Anesthesia Without Muscle Relaxation During Pediatric High-Risk Adenotonsillectomy: A Randomized-Controlled Trial

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?
Read more

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.

Read the detailed description

This will be a randomized, patient- and assessor-blinded, parallel arm, controlled trial assessing the efficacy of neuromuscular blockade with reversal during the anesthetic management of pediatric adenotonsillectomy (AT) to reduce intra- and postoperative opioid consumption and postoperative respiratory events in high-risk patients. Enrolled participants will be randomized by computer-generated assignment using stratified blocked randomization with a 1:1 allocation into 2 arms: neuromuscular blockade with reversal at the end of surgery and no neuromuscular blockade. Randomization will occur on the following strata: severe versus non-severe obstructive sleep apnea (OSA)/sleep disordered breathing. Patients/families, treating teams (except for the anesthesia team), and research staff/investigators responsible for measuring and adjudicating outcomes will be blinded to allocation.

Primary Efficacy Objective - Evaluate intraoperative and postoperative opioid consumption in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex.

Secondary Objectives - (1) Evaluate postoperative respiratory events in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex. The outcome of postoperative respiratory events will be a composite measure consisting of 1) airway obstruction or hypoxemia, defined as SpO2 less than 90 percent, requiring any of the following interventions: supplemental oxygen by nasal cannula or simple face mask, noninvasive positive airway pressure, or reintubation; or 2) unanticipated intensive care unit (ICU) admission. (2) Evaluate postoperative low minute ventilation (MV) episodes, defined as MV less than 40 percent predicted for at least 2 minutes and measured by a respiratory volume monitor (RVM), in high-risk children having AT without muscle relaxation or with neuromuscular blocks and reversal with sugammadex.

Conditions
Tonsillectomy
Being tested
Rocuronium, Sugammadex, Anesthesia without neuromuscular blockade
Keywords
Sleep Apnea, Obstructive, Child, Snoring, Sleep Apnea Syndromes
Medical subject headings
Sleep Apnea, Obstructive, Snoring, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RocuroniumDrug

    Also called Neuromuscular blocking agent, Paralytic, Zemuron, Esmeron

    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.

  • SugammadexDrug

    Also called Bridion, Neuromuscular blocking agent reversal, Neuromuscular blocking drug reversal, Paralytic reversal

    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.

  • Anesthesia without neuromuscular blockadeOther

    Anesthesia without rocuronium or sugammadex

Study groups in NCT06225466
Study groupRoleWhat they receive
Neuromuscular blockadeActive comparatorRocuronium 0.6 mg/kg IV (max 50 mg) intraop with repeated doses of 0.2 mg/kg (max 15 mg) as indicated. Sugammadex 2-4 mg/kg IV at the end of surgery. SOC drugs: 1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. 2. Sevoflurane induction and maintenance of anesthesia 3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop 4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop 5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses). 6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop 7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours. Device monitoring: 1. Bispectral index system intraop 2. TetraGraph neuromuscular transmission monitor intraop 3. ExSpiron respiratory volume monitor intraop and in PACU
Receives: Drug: Rocuronium; Drug: Sugammadex
No neuromuscular blockadeOtherAnesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered. SOC drugs: 1. Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery. 2. Sevoflurane induction and maintenance of anesthesia 3. Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop 4. Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop 5. Fentanyl at the discretion of the anesthesiologist. In the post-anesthesia care unit (PACU), fentanyl 0.5 mcg/kg IV (max 25 mcg) for pain score 4 or greater (max 3 doses). 6. Ondansetron 0.1 mg/kg (max 4 mg) IV intraop 7. Ibuprofen 10 mg/kg (max 500 mg) PO every 6 hours beginning after surgery and alternating with acetaminophen 15 mg/kg (max 800 mg) every 6 hours. Device monitoring: 1. Bispectral index system intraop 2. ExSpiron respiratory volume monitor intraop and in PACU
Receives: Other: Anesthesia without neuromuscular blockade

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Intra- and Postoperative Opioid Consumption

    Continuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight

    Measured: From surgery start to discharge home, up to 24 hours

Secondary outcomes (2)

  1. Number of Participants With Postoperative Respiratory Events

    Composite binary outcome consisting of 1) airway obstruction or hypoxemia, defined as SpO2 <90%, requiring any of the following interventions: supplemental oxygen by nasal cannula or simple face mask, noninvasive positive airway pressure, or reintubation; or 2) unanticipated ICU admission.

    Measured: From post-anesthesia care unit admission to discharge home, up to 24 hours

  2. Number of Low Minute Ventilation (MV) Events in the Post-anesthesia Care Unit

    Count outcome of distinct episodes of low MV.

    MV - the product of respiratory rate and tidal volume - was continuously measured by a noninvasive respiratory volume monitor. Low MV events were defined as episodes of MV less than 40 percent predicted - calculated by the monitor based on the patient's body surface area - for at least two minutes. This definition is routinely used by the monitoring system.

    Measured: From post-anesthesia care unit admission to transfer to the postoperative ward, up to 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2024
  2. Study start10 Apr 2024
  3. Primary completion27 Sep 2024
  4. Study completion27 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, patient- and assessor-blinded, parallel arm, controlled trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06225466
Sponsor's protocol ID
STU2023-0851
Status last verified
Jul 2025
First submitted
16 Jan 2024
Last updated
28 Jul 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with the NIH's Data Management Sharing Policy and recent focus in the scientific community on data sharing, all collected deidentified individual participant data will be stored in the UTSW Data Repository, an open access data repository for researchers affiliated with UTSW.

Publications

  • Johnson RF, Zhang J, Chorney SR, Kou YF, Lenes-Voit F, Ulualp S, Liu C, Mitchell RB. Estimations of Inpatient and Ambulatory Pediatric Tonsillectomy in the United States: A Cross-sectional Analysis. Otolaryngol Head Neck Surg. 2023 Aug;169(2):258-266. doi: 10.1002/ohn.268. Epub 2023 Feb 5.

    PubMed 36939461

  • Rossi NA, Spaude J, Ohlstein JF, Pine HS, Daram S, McKinnon BJ, Szeremeta W. Apnea-hypopnea index severity as an independent predictor of post-tonsillectomy respiratory complications in pediatric patients: A retrospective study. Ear Nose Throat J. 2024 Jul;103(7):424-429. doi: 10.1177/01455613211059468. Epub 2021 Dec 1.

    PubMed 34851765

  • Smith DF, Spiceland CP, Ishman SL, Engorn BM, Donohue C, Park PS, Benke JR, Frazee T, Brown RH, Dalesio NM. Admission Criteria for Children With Obstructive Sleep Apnea After Adenotonsillectomy: Considerations for Cost. J Clin Sleep Med. 2017 Dec 15;13(12):1463-1472. doi: 10.5664/jcsm.6850.

    PubMed 29117883

  • Allareddy V, Martinez-Schlurmann N, Rampa S, Nalliah RP, Lidsky KB, Allareddy V, Rotta AT. Predictors of Complications of Tonsillectomy With or Without Adenoidectomy in Hospitalized Children and Adolescents in the United States, 2001-2010: A Population-Based Study. Clin Pediatr (Phila). 2016 Jun;55(7):593-602. doi: 10.1177/0009922815616885. Epub 2015 Nov 24.

    PubMed 26603580

  • Mitchell RB, Archer SM, Ishman SL, Rosenfeld RM, Coles S, Finestone SA, Friedman NR, Giordano T, Hildrew DM, Kim TW, Lloyd RM, Parikh SR, Shulman ST, Walner DL, Walsh SA, Nnacheta LC. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol Head Neck Surg. 2019 Feb;160(1_suppl):S1-S42. doi: 10.1177/0194599818801757.

    PubMed 30798778

  • Voss T, Wang A, DeAngelis M, Speek M, Saldien V, Hammer GB, Wrishko R, Herring WJ. Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study. Paediatr Anaesth. 2022 Mar;32(3):436-445. doi: 10.1111/pan.14370. Epub 2021 Dec 17.

    PubMed 34878707

  • Kou YF, Sakai M, Shah GB, Mitchell RB, Johnson RF. Postoperative respiratory complications and racial disparities following inpatient pediatric tonsillectomy: A cross-sectional study. Laryngoscope. 2019 Apr;129(4):995-1000. doi: 10.1002/lary.27405. Epub 2018 Nov 9.

    PubMed 30412279

  • Cote CJ, Posner KL, Domino KB. Death or neurologic injury after tonsillectomy in children with a focus on obstructive sleep apnea: houston, we have a problem! Anesth Analg. 2014 Jun;118(6):1276-83. doi: 10.1213/ANE.0b013e318294fc47.

    PubMed 23842193

  • Goldman JL, Baugh RF, Davies L, Skinner ML, Stachler RJ, Brereton J, Eisenberg LD, Roberson DW, Brenner MJ. Mortality and major morbidity after tonsillectomy: etiologic factors and strategies for prevention. Laryngoscope. 2013 Oct;123(10):2544-53. doi: 10.1002/lary.23926. Epub 2013 Apr 17.

    PubMed 23595509

  • Baldo BA, Rose MA. Mechanisms of opioid-induced respiratory depression. Arch Toxicol. 2022 Aug;96(8):2247-2260. doi: 10.1007/s00204-022-03300-7. Epub 2022 Apr 26.

    PubMed 35471232

  • Waters KA, McBrien F, Stewart P, Hinder M, Wharton S. Effects of OSA, inhalational anesthesia, and fentanyl on the airway and ventilation of children. J Appl Physiol (1985). 2002 May;92(5):1987-94. doi: 10.1152/japplphysiol.00619.2001.

    PubMed 11960949

  • Dalesio NM, Lee CKK, Hendrix CW, Kerns N, Hsu A, Clarke W, Collaco JM, McGrath-Morrow S, Yaster M, Brown RH, Schwartz AR. Effects of Obstructive Sleep Apnea and Obesity on Morphine Pharmacokinetics in Children. Anesth Analg. 2020 Sep;131(3):876-884. doi: 10.1213/ANE.0000000000004509.

    PubMed 31688081

  • Gozal D, Burnside MM. Increased upper airway collapsibility in children with obstructive sleep apnea during wakefulness. Am J Respir Crit Care Med. 2004 Jan 15;169(2):163-7. doi: 10.1164/rccm.200304-590OC. Epub 2003 Oct 2.

    PubMed 14525806

  • Marcus CL, McColley SA, Carroll JL, Loughlin GM, Smith PL, Schwartz AR. Upper airway collapsibility in children with obstructive sleep apnea syndrome. J Appl Physiol (1985). 1994 Aug;77(2):918-24. doi: 10.1152/jappl.1994.77.2.918.

    PubMed 8002548

  • Brown KA, Laferriere A, Moss IR. Recurrent hypoxemia in young children with obstructive sleep apnea is associated with reduced opioid requirement for analgesia. Anesthesiology. 2004 Apr;100(4):806-10; discussion 5A. doi: 10.1097/00000542-200404000-00009.

    PubMed 15087614

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rocuronium, Sugammadex and Anesthesia without neuromuscular blockade in people with Tonsillectomy, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Intra- and Postoperative Opioid Consumption (time frame: From surgery start to discharge home, up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06225466, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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