Muscle Relaxation for Pediatric Adenotonsillectomy

April 10, 2024 updated by: Proshad Efune, MD, University of Texas Southwestern Medical Center

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?

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Children's Health Dallas
        • Contact:
        • Principal Investigator:
          • Proshad Efune, MD
        • Sub-Investigator:
          • Rita Saynhalath, MD
        • Sub-Investigator:
          • Peter Szmuk, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neuromuscular blockade

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
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.
Other Names:
  • Zemuron
  • Esmeron
  • Neuromuscular blocking agent
  • Paralytic
  • Neuromuscular blocking drug
  • Nondepolarizing neuromuscular blocker
  • Nondepolarizing neuromuscular blocking agent
  • Nondepolarizing neuromuscular blocking drug
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.
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
Other: No neuromuscular blockade

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
Anesthesia without rocuronium or sugammadex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative intra- and postoperative opioid consumption
Time Frame: From surgery start to discharge home, up to 24 hours
Continuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight
From surgery start to discharge home, up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with postoperative respiratory events
Time Frame: From post-anesthesia care unit admission to discharge home, up to 24 hours
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.
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
Time Frame: From post-anesthesia care unit admission to transfer to the postoperative ward, up to 8 hours
Count outcome of distinct episodes of MV less than 40 percent predicted for at least 2 minutes
From post-anesthesia care unit admission to transfer to the postoperative ward, up to 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Proshad Efune, MD, UT Southwestern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

January 16, 2024

First Submitted That Met QC Criteria

January 24, 2024

First Posted (Actual)

January 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU2023-0851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Starting 6 months after publication, for a period of 5 years

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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