Assessment of Regional Anesthetic Blockade Using Non-Invasive Surface Electromyogram (EMG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
研究概览
简要总结
This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies.
详细描述
This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize neuraxial anesthesia (i.e. spinal and caudal blockade) in pediatric patients undergoing surgery. The investigators will also attempt to measure the effect of adjunctive intrathecal clonidine on spinal and caudal blockade using EMG. This study also aims to quantify the impact of sevoflurane on basal muscle tone based on EMG changes. This study aims to generate pilot data on this subject to help design future studies. The hypothesis is that EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Only the individuals performing data analysis will be blinded to type of anesthetic technique performed.
入排标准
- 年龄范围
- 0 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1 (GA + penile block): age 5 years or below getting: circumcision or circumcision revision
- •Group 2-5 (SA or GA + CA): age 5 years or below getting: penile or scrotal surgery, inguinal hernia repair, Achilles tendon lengthening, other applicable urological procedures
- •Group 6 (GA only): age 5 years or below getting: operative dentistry, urological or ENT procedures
排除标准
- •parent refusal
- •systemic infection
- •spine or CNS abnormalities
- •medication allergy
- •adhesive allergy
研究组 & 干预措施
Spinal Anesthesia with Clonidine
Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.
干预措施: BlockSynop surface electromyography device (Device)
Spinal Anesthesia with Clonidine
Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.
干预措施: Clonidine (Drug)
General Anesthesia with Caudal Anesthesia without Clonidine
Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg
干预措施: Sevoflurane (Drug)
General Anesthesia with Caudal Anesthesia with Clonidine
Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.
干预措施: Sevoflurane (Drug)
General Anesthesia with Caudal Anesthesia with Clonidine
Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.
干预措施: BlockSynop surface electromyography device (Device)
General Anesthesia with Caudal Anesthesia without Clonidine
Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg
干预措施: BlockSynop surface electromyography device (Device)
General Anesthesia only
GA alone: Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
干预措施: BlockSynop surface electromyography device (Device)
General Anesthesia with Caudal Anesthesia with Clonidine
Caudal block: single-shot caudal injection following induction of GA with 1mL/kg of 0.25% bupivacaine with 1:200,000 epinephrine, with or without clonidine 1mcg/kg Clonidine is an FDA approved medication that is commonly administered as an adjunct to SA and CA in this population.
干预措施: Clonidine (Drug)
Spinal Anesthesia without Clonidine
Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine
干预措施: BlockSynop surface electromyography device (Device)
General Anesthesia with Penile Block
Penile block: prior to the start of surgery 0.5mg/kg of 0.25% bupivacaine w/o epinephrine will be administered GA : Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
干预措施: BlockSynop surface electromyography device (Device)
General Anesthesia only
GA alone: Inhalation induction with sevoflurane followed by peripheral IV access, and placement of an endotracheal tube or laryngeal mask airway. No intravenous neuromuscular blockade will be given. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
时间窗: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.
Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. .
时间窗: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.
Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
时间窗: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.
Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
时间窗: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.
次要结局
- Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the onset of SA or CA and measured by the power of signal amplitude.(Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.)
- Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the duration of SA or CA and measured by the power of signal amplitude.(Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.)
- Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the density of SA or CA and measured by the power of signal amplitude.(Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.)
- Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used as defined as the dermatomal level of SA or CA and measured by the power of signal amplitude.(Intraoperative time frame through motor blockade in the PACU. Timeframe being day of surgery.)
- Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.(Intraoperative time frame. Timeframe being day of surgery.)
研究者
Grant Heydinger
Principal Investigator - MD
Nationwide Children's Hospital