Clinical trial NCT06225466
Conditions: Tonsillectomy
Keywords: Sleep Apnea, Obstructive Child Snoring Sleep Apnea Syndromes
Sponsor: University of Texas Southwestern Medical Center
Start date: 2024-04-10; Completion date: 2024-09-27
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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. 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.

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.

Arms: arm 1: 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 arm 2: 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
Interventions: intervention 1: Rocuronium intervention 2: Sugammadex intervention 3: Anesthesia without neuromuscular blockade
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Anesthesia without rocuronium or sugammadex

Protocol documents:
Prot_SAP_000.pdf: 
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