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Regional Anesthesia with Clonidine for Surgery

N/A

Recruiting

Led By Grant Heydinger, MD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Systemic infection

Parent refusal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraoperative time frame. timeframe being day of surgery.

Awards & highlights

No Placebo-Only Group

Summary

This trial will use a non-invasive monitoring technique called EMG to study how spinal and caudal anesthesia works in children during surgery. They will also look at how adding clonidine affects the

Who is the study for?

This trial is for pediatric patients needing surgery where spinal or caudal blockade anesthesia will be used. It's designed to test a non-invasive EMG monitoring device during the operation. Patients with conditions that might interfere with EMG readings or those who can't receive the study drugs may not qualify.

What is being tested?

The study tests how well an EMG device can track anesthesia effects in real-time during surgery. It also looks at whether adding clonidine to the anesthesia affects these readings, and it examines sevoflurane's impact on muscle tone through EMG data.

What are the potential side effects?

Possible side effects include typical reactions to clonidine like low blood pressure, dry mouth, and sedation; as well as common responses to sevoflurane such as nausea and shivering post-surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 5 years old or younger and need a circumcision or its revision.

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My child is 5 or younger and needs specific surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a body-wide infection.

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My parents have refused participation in the trial.

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I have spine or brain abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preoperative placement through resolution of motor blockade in the pacu. timeframe being day of surgery - up to one day.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preoperative placement through resolution of motor blockade in the pacu. timeframe being day of surgery - up to one day.

This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative placement through resolution of motor blockade in the pacu. timeframe being day of surgery - up to one day. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine density of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.

Determine dermatomal level of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude.

Determine duration of spinal anesthesia and caudal + general anesthesia using surface EMG as measured by power of signal amplitude. .

+1 more

Secondary study objectives

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 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 as defined as the duration of SA or CA and measured by the power of signal amplitude.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Active Control

Group I: General Anesthesia with Penile BlockActive Control1 Intervention

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.

Group II: General Anesthesia onlyActive Control2 Interventions

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.

Group III: General Anesthesia with Caudal Anesthesia with ClonidineActive Control3 Interventions

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.

Group IV: Spinal Anesthesia without ClonidineActive Control1 Intervention

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

Group V: General Anesthesia with Caudal Anesthesia without ClonidineActive Control2 Interventions

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

Group VI: Spinal Anesthesia with ClonidineActive Control2 Interventions

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.

0 / 5Eligibility criteria met