Muscle Relaxation for Pediatric Adenotonsillectomy

NCT06225466 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STU2023-0851
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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. 1.What is the impact of general anesthesia with muscle relaxation on opioid pain medication requirements during and after adenotonsillectomy?
2. 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?

Conditions

Tonsillectomy

Keywords

Sleep Apnea, Obstructive; Child; Snoring; Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

• Cumulative Intra- and Postoperative Opioid Consumption

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

  From surgery start to discharge home, up to 24 hours

Secondary Outcomes (2)

• Number of Participants With Postoperative Respiratory Events

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

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

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

Study Arms (2)

Neuromuscular blockade

ACTIVE COMPARATOR

Rocuronium 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

Drug: Rocuronium; Drug: Sugammadex

No neuromuscular blockade

OTHER

Anesthesia 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

Other: Anesthesia without neuromuscular blockade

Interventions

Rocuronium DRUG

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.

Also known as: Neuromuscular blocking agent, Paralytic, Zemuron, Esmeron, Neuromuscular blocking drug, Nondepolarizing neuromuscular blocker, Nondepolarizing neuromuscular blocking agent, Nondepolarizing neuromuscular blocking drug

Neuromuscular blockade

Sugammadex DRUG

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.

Also known as: 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

Neuromuscular blockade

Anesthesia without neuromuscular blockade OTHER

Anesthesia without rocuronium or sugammadex

No neuromuscular blockade

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Children's Health Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (24)

• 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.

  PMID: 36939461 BACKGROUND

• 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.

  PMID: 34851765 BACKGROUND

• 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.

  PMID: 29117883 BACKGROUND

• 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.

  PMID: 26603580 BACKGROUND

• 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.

  PMID: 30798778 BACKGROUND

• 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.

  PMID: 34878707 BACKGROUND

• 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.

  PMID: 30412279 BACKGROUND

• 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.

  PMID: 23842193 BACKGROUND

• 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.

  PMID: 23595509 BACKGROUND

• 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.

  PMID: 35471232 BACKGROUND

• 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.

  PMID: 11960949 BACKGROUND

• 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.

  PMID: 31688081 BACKGROUND

• 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.

  PMID: 14525806 BACKGROUND

• 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.

  PMID: 8002548 BACKGROUND

• 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.

  PMID: 15087614 BACKGROUND

• von Ungern-Sternberg BS, Sommerfield D, Slevin L, Drake-Brockman TFE, Zhang G, Hall GL. Effect of Albuterol Premedication vs Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: The REACT Randomized Clinical Trial. JAMA Pediatr. 2019 Jun 1;173(6):527-533. doi: 10.1001/jamapediatrics.2019.0788.

  PMID: 31009034 BACKGROUND

• Shen F, Zhang Q, Xu Y, Wang X, Xia J, Chen C, Liu H, Zhang Y. Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225473. doi: 10.1001/jamanetworkopen.2022.25473.

  PMID: 35943745 BACKGROUND

• Efune PN, Longanecker JM, Alex G, Saynhalath R, Khan U, Rivera K, Jerome AP, Boone W, Szmuk P. Use of dexmedetomidine and opioids as the primary anesthetic in infants and young children: A retrospective cohort study. Paediatr Anaesth. 2020 Sep;30(9):1013-1019. doi: 10.1111/pan.13945. Epub 2020 Jul 26.

  PMID: 32510703 BACKGROUND

• Efune PN, Saynhalath R, Blackwell JM, Steiner JW, Olomu PN, Szmuk P. The Truview PCD video laryngoscope for nasotracheal intubation in pediatric patients: A subset analysis from a prospective randomized controlled trial. Paediatr Anaesth. 2020 Oct;30(10):1157-1158. doi: 10.1111/pan.14005. Epub 2020 Sep 6. No abstract available.

  PMID: 32805748 BACKGROUND

• Saynhalath R, Alex G, Efune PN, Szmuk P, Zhu H, Sanford EL. Anesthetic Complications Associated With Severe Acute Respiratory Syndrome Coronavirus 2 in Pediatric Patients. Anesth Analg. 2021 Aug 1;133(2):483-490. doi: 10.1213/ANE.0000000000005606.

  PMID: 33886516 BACKGROUND

• Hamilton TB, Thung A, Tobias JD, Jatana KR, Raman VT. Adenotonsillectomy and postoperative respiratory adverse events: A retrospective study. Laryngoscope Investig Otolaryngol. 2020 Jan 3;5(1):168-174. doi: 10.1002/lio2.340. eCollection 2020 Feb.

  PMID: 32128445 BACKGROUND

• Templeton TW, Goenaga-Diaz EJ, Downard MG, McLouth CJ, Smith TE, Templeton LB, Pecorella SH, Hammon DE, O'Brien JJ, McLaughlin DH, Lawrence AE, Tennant PR, Ririe DG. Assessment of Common Criteria for Awake Extubation in Infants and Young Children. Anesthesiology. 2019 Oct;131(4):801-808. doi: 10.1097/ALN.0000000000002870.

  PMID: 31343462 BACKGROUND

• Chisholm AG, Sathyamoorthy M, Seals SR, Carron JD. Does intravenous acetaminophen reduce perioperative opioid use in pediatric tonsillectomy? Am J Otolaryngol. 2019 Nov-Dec;40(6):102294. doi: 10.1016/j.amjoto.2019.102294. Epub 2019 Sep 9.

  PMID: 31521403 BACKGROUND

• Lammers CR, Schwinghammer AJ, Hall B, Kriss RS, Aizenberg DA, Funamura JL, Senders CW, Nittur V, Applegate RL 2nd. Comparison of Oral Loading Dose to Intravenous Acetaminophen in Children for Analgesia After Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial. Anesth Analg. 2021 Dec 1;133(6):1568-1576. doi: 10.1213/ANE.0000000000005678.

  PMID: 34304234 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring; Sleep Apnea Syndromes

Interventions

Rocuronium; Neuromuscular Blocking Agents; Sugammadex; Anesthesia; Neuromuscular Blockade

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Anesthesia and Analgesia; Investigative Techniques

Results Point of Contact

• Title: Dr. Proshad Efune
• Organization: University of Texas Southwestern Medical Center

proshad.efune@utsouthwestern.edu

2144566393

Study Officials

• Proshad Efune, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients/families, treating teams (except for the anesthesia team), and research staff/investigators responsible for measuring and adjudicating outcomes will be blinded to allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized, patient- and assessor-blinded, parallel arm, controlled trial

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 26, 2024
• Study Start: April 10, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: July 28, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication, for a period of 5 years
• Access Criteria: The UT Southwestern Research Data Repository is an open access data repository for researchers affiliated with the UT Southwestern Medical Center. The repository consists of datasets produced by the University community, available for public access and re-use. Each dataset includes citation information and a Digital Object Identifier (DOI), facilitating attribution, usage tracking, and linking of data to research publications. Human research data may only be included if data are deidentified and the IRB has approved the sharing of the data on that repository.

Locations

US (1)