SurgeryNCT06287151
Regional Anesthesia EMG Study
A study testing BlockSynop surface electromyography device, Clonidine and Sevoflurane in people with Surgery, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- Surgery
- What is being tested?
- BlockSynop surface electromyography device, Clonidine and Sevoflurane
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- parent refusal
- systemic infection
- spine or CNS abnormalities
- medication allergy
- adhesive allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Assessment of Regional Anesthetic Blockade Using Non-Invasive Surface Electromyogram (EMG)
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.
Read the detailed 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.
- Conditions
- Surgery
- Being tested
- BlockSynop surface electromyography device, Clonidine, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlockSynop surface electromyography deviceDevice
The EMG monitor uses non-invasive surface electrodes that measures electrical activity in response to muscle stimulation. After all electrodes have been placed on the patient, the electrodes will be connected to a prototype non-significant risk device (NSR) BlockSynop surface electromyography device and monitoring of sEMG signal will begin. The device is a non-invasive and non-significant risk device.
ClonidineDrug
Clonidine is an alpha-2-agonist which is commonly used as an adjunct in spinal anesthesia and caudal anesthesia to improve both the quality and duration of blockade.
SevofluraneDrug
5.3. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia with Penile Block | Active comparator | 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. Receives: Device: BlockSynop surface electromyography device |
| Spinal Anesthesia with Clonidine | Active comparator | 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. Receives: Device: BlockSynop surface electromyography device; Drug: Clonidine |
| Spinal Anesthesia without Clonidine | Active comparator | Spinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine Receives: Device: BlockSynop surface electromyography device |
| General Anesthesia with Caudal Anesthesia with Clonidine | Active comparator | 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. Receives: Device: BlockSynop surface electromyography device; Drug: Clonidine; Drug: Sevoflurane |
| General Anesthesia with Caudal Anesthesia without Clonidine | Active comparator | 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 Receives: Device: BlockSynop surface electromyography device; Drug: Sevoflurane |
| General Anesthesia only | Active comparator | 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. Receives: Device: BlockSynop surface electromyography device; Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.
Measured: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. .
Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.
Measured: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.
Measured: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
Performance of non-invasive surface EMG following administration of regional and/or general anesthesia. This will be assessed by EMG signal amplitude.
Measured: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Secondary outcomes (5)
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.
Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.
Measured: 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.
Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.
Measured: 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.
Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.
Measured: 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.
Determine objective effect of clonidine, a common additive to neuraxial blockade in children on the measures described above when SA and CA are used.
Measured: 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.
Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.
Measured: Intraoperative time frame. Timeframe being day of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start9 Aug 2023
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Choice of group will be made by attending anesthesiologist based on clinical judgement.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant Heydinger, Nationwide Children's Hospital
- Investigators
- Grant Heydinger, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287151
- Sponsor's protocol ID
- STUDY00002844
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Regional Anesthetic Blockade Using Non-Invasive Surface Electromyogram (EMG)
- ClinicalTrials.gov ID
- NCT06287151
- Acronym / sponsor ID
- STUDY00002844
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Choice of group will be made by attending anesthesiologist based on clinical judgement.
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia with Penile Block | Active comparator | Device: BlockSynop surface electromyography devicePenile 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. |
| Spinal Anesthesia with Clonidine | Active comparator | Device: BlockSynop surface electromyography device, Drug: ClonidineSpinal 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. |
| Spinal Anesthesia without Clonidine | Active comparator | Device: BlockSynop surface electromyography deviceSpinal block: 0.5% isobaric bupivacaine with 1:200,000 epinephrine (0.2mL/kg up to 1mL), with or without 1mcg/kg clonidine |
| General Anesthesia with Caudal Anesthesia with Clonidine | Active comparator | Device: BlockSynop surface electromyography device, Drug: Clonidine, Drug: SevofluraneCaudal 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. |
| General Anesthesia with Caudal Anesthesia without Clonidine | Active comparator | Device: BlockSynop surface electromyography device, Drug: SevofluraneCaudal 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 |
| General Anesthesia only | Active comparator | Device: BlockSynop surface electromyography device, Drug: SevofluraneGA 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. |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- parent refusal
- systemic infection
- spine or CNS abnormalities
- medication allergy
- adhesive allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlockSynop surface electromyography deviceThe EMG monitor uses non-invasive surface electrodes that measures electrical activity in response to muscle stimulation. After all electrodes have been placed on the patient, the electrodes will be connected to a prototype non-significant risk device (NSR) BlockSynop surface electromyography device and monitoring of sEMG signal will begin. The device is a non-invasive and non-significant risk device. | Device | General Anesthesia only, General Anesthesia with Caudal Anesthesia with Clonidine, General Anesthesia with Caudal Anesthesia without Clonidine, General Anesthesia with Penile Block, Spinal Anesthesia with Clonidine, Spinal Anesthesia without Clonidine |
| ClonidineClonidine is an alpha-2-agonist which is commonly used as an adjunct in spinal anesthesia and caudal anesthesia to improve both the quality and duration of blockade. | Drug | General Anesthesia with Caudal Anesthesia with Clonidine, Spinal Anesthesia with Clonidine |
| Sevoflurane5.3. Sevoflurane is FDA approved for the induction and maintenance of general anesthesia in adults and pediatric patients. | Drug | General Anesthesia only, General Anesthesia with Caudal Anesthesia with Clonidine, General Anesthesia with Caudal Anesthesia without Clonidine |
Primary outcome
Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
Time frame: 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. .
Time frame: 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 density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.
Time frame: 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.
Time frame: 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.
5 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Intraoperative time frame. Timeframe being day of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Heydinger, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BlockSynop surface electromyography device, Clonidine and Sevoflurane in people with Surgery, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine onset of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. (time frame: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.