Anesthesia With Neuromuscular Blockade and Reversal With Sugammadex Compared to Anesthesia Without Muscle Relaxation During Pediatric High-Risk Adenotonsillectomy: A Randomized-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Cumulative Intra- and Postoperative Opioid Consumption
研究概览
简要总结
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:
- What is the impact of general anesthesia with muscle relaxation on opioid pain medication requirements during and after adenotonsillectomy?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Patients/families, treating teams (except for the anesthesia team), and research staff/investigators responsible for measuring and adjudicating outcomes will be blinded to allocation.
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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:
- Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
- Sevoflurane induction and maintenance of anesthesia
- Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
- Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
- 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).
- Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
- 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:
- Bispectral index system intraop
- TetraGraph neuromuscular transmission monitor intraop
- ExSpiron respiratory volume monitor intraop and in PACU
干预措施: Rocuronium (Drug)
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:
- Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
- Sevoflurane induction and maintenance of anesthesia
- Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
- Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
- 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).
- Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
- 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:
- Bispectral index system intraop
- TetraGraph neuromuscular transmission monitor intraop
- ExSpiron respiratory volume monitor intraop and in PACU
干预措施: Sugammadex (Drug)
No neuromuscular blockade
Anesthesia will be administered in a standard fashion. Rocuronium and sugammadex will not be administered.
SOC drugs:
- Midazolam 0.5 mg/kg (max 15 mg) and acetaminophen 15 mg/kg (max 800 mg) PO 20-30 minutes before surgery.
- Sevoflurane induction and maintenance of anesthesia
- Dexamethasone 0.5 mg/kg IV (max 8 mg) intraop
- Dexmedetomidine 0.3 mcg/kg IV (max 12 mcg) intraop
- 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).
- Ondansetron 0.1 mg/kg (max 4 mg) IV intraop
- 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:
- Bispectral index system intraop
- ExSpiron respiratory volume monitor intraop and in PACU
干预措施: Anesthesia without neuromuscular blockade (Other)
结局指标
主要结局
Cumulative Intra- and Postoperative Opioid Consumption
时间窗: From surgery start to discharge home, up to 24 hours
Continuous outcome of intravenous morphine milligram equivalents (MME) per kg of body weight
次要结局
- 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)
研究者
Proshad Efune, MD
Assistant Professor
University of Texas Southwestern Medical Center