Regional Anesthesia EMG Study

Nationwide Children's Hospital

Status: Active, not recruiting

Conditions: Surgery

Treatments: Drug: Clonidine; Device: BlockSynop surface electromyography device; Drug: Sevoflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT06287151

STUDY00002844

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• parent refusal
• systemic infection
• spine or CNS abnormalities
• medication allergy
• adhesive allergy

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 6 patient groups

General Anesthesia with Penile Block

Active Comparator group

Description:

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.

Treatment:

Device: BlockSynop surface electromyography device

Spinal Anesthesia with Clonidine

Active Comparator group

Description:

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.

Treatment:

Device: BlockSynop surface electromyography device

Drug: Clonidine

Spinal Anesthesia without Clonidine

Active Comparator group

Description:

Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine

Treatment:

Device: BlockSynop surface electromyography device

General Anesthesia with Caudal Anesthesia with Clonidine

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane

Device: BlockSynop surface electromyography device

Drug: Clonidine

General Anesthesia with Caudal Anesthesia without Clonidine

Active Comparator group

Description:

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

Treatment:

Drug: Sevoflurane

Device: BlockSynop surface electromyography device

General Anesthesia only

Active Comparator group

Description:

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.

Treatment:

Drug: Sevoflurane

Device: BlockSynop surface electromyography device