Regional Anesthesia with Clonidine for Surgery
Recruiting in Palo Alto (17 mi)
Overseen byGrant Heydinger, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nationwide Children's Hospital
Disqualifiers: Systemic infection, Spine abnormalities, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the drug clonidine for regional anesthesia in surgery?
Research shows that clonidine, when added to local anesthetics, can prolong the duration of anesthesia and pain relief after certain types of nerve blocks, such as the axillary brachial plexus block, and improve the effectiveness of postoperative pain management in major surgeries.
12345Is clonidine safe for use in regional anesthesia?
Research shows that clonidine, when used as an additive in local anesthesia, does not significantly increase the risk of adverse events like low heart rate, low blood pressure, nausea, dizziness, or dry mouth compared to other similar drugs.
26789How does the drug clonidine differ from other treatments for regional anesthesia?
Clonidine, when used as an additive to local anesthetics in regional anesthesia, enhances the effects by reducing the onset time, improving efficacy, and prolonging the duration of pain relief after surgery. This makes it unique compared to standard local anesthetics, which may not provide as long-lasting or effective pain control on their own.
2371011Eligibility Criteria
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.Inclusion Criteria
I am 5 years old or younger and need a circumcision or its revision.
I am 5 years old or younger and need surgery for dental, urological, or ENT issues.
My child is 5 or younger and needs specific surgery.
Exclusion Criteria
Medication allergy
I have a body-wide infection.
My parents have refused participation in the trial.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Intraoperative EMG monitoring to assess neuraxial anesthesia and the effect of adjunctive intrathecal clonidine
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
1 day
1 visit (in-person)
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nationwide Children's HospitalColumbus, OH
Loading ...
Who Is Running the Clinical Trial?
Nationwide Children's HospitalLead Sponsor
References
Does epidural clonidine improve postoperative analgesia in major vascular surgery? [2022]To determine the quality and duration of the analgesic and haemodynamic effects of clonidine when used as an additional analgesic for postoperative epidural analgesia in major vascular surgery.
Efficacy of Clonidine as an Additive on the Duration of Action of Brachial Plexus Block Performed Under Ultrasound and Nerve Locator Guidance: A Prospective Randomized Study. [2022]Label="BACKGROUND" NlmCategory="BACKGROUND">Clonidine, an alpha2 agonist, when added to local anesthetics in different regional and neuraxial blocks reduces the onset time, improves the efficacy, and increases the duration of postoperative analgesia.
Adding clonidine to mepivacaine prolongs the duration of anesthesia and analgesia after axillary brachial plexus block. [2013]This study evaluates the effects of clonidine added to mepivacaine on the duration of anesthesia and analgesia after axillary brachial plexus block.
Oral clonidine premedication does not prolong analgesia after herniorrhaphy under subarachnoid anesthesia. [2019]To determine the effect of oral clonidine premedication on duration of sensory and motor block, postoperative analgesia, hemodynamic stability, sedation, and respiratory parameters after subarachnoid anesthesia (SA).
Clonidine as an Adjuvant to Bupivacaine for Suprazygomatic Maxillary Nerve Blocks in Cleft lip and Palate Repair: A Randomized, Prospective, Double-Blind Study. [2021]Does clonidine, as adjuvant to bupivacaine for suprazygomatic maxillary nerve blocks, reduce emergence agitation in patients undergoing cleft lip and cleft palate surgery?
Clinical Evaluation of Two Different Doses of Clonidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Pediatric Upper Limb Surgeries - A Randomized Trial. [2022]Clonidine as an adjuvant to local anesthetic for regional anesthesia in upper limb surgeries has been extensively studied in adults, but there is a paucity of data regarding the dose of clonidine which is effective and safe as an adjuvant in children.
Improving postoperative analgesia after axillary brachial plexus anesthesia with 0.75% ropivacaine. A double-blind evaluation of adding clonidine. [2022]The aim of this prospective, randomized, double-blind study was to evaluate the effects of adding 1 microg/kg clonidine to 20 ml of ropivacaine 0.75% for axillary brachial plexus anesthesia.
Comparative Study of the Adverse Events Associated With Adjuvant Use of Dexmedetomidine and Clonidine in Local Anesthesia. [2021]Background: Although clonidine and dexmedetomidine are used as alpha-2 agonists to improve the quality and duration of blockade induced by local anesthetics, no study has been reported to compare their associated adverse events in local anesthesia. The aim of this study is to compare the adverse events associated with the adjuvant use of dexmedetomidine and clonidine in local anesthesia. Methods: A comprehensive search was performed to retrieve any reported adverse event associated with adjuvant use of dexmedetomidine and clonidine in local anesthesia from published literature up to 1 July 2020. Assessment of the quality of included studies was performed by the Jadad score. A comparison of any reported adverse event was made between interventions by pooling data from studies using a direct meta-analysis technique. Dichotomous outcomes were summarized as risk ratios. The review was performed according to PRISMA guideline. Results: From 121 articles retrieved from the search finally 14 articles including 1,120 patients had eligibility criteria for including in the meta-analysis. No significant difference was observed between bradycardia/hypotension (OR = 1.17; 95 % CI = 0.66-2.10; P = 0.580; I 2 = 53.78 %, P = 0.027), nausea/vomiting (OR = 0.91; 95% CI = 0.59-1.42; P = 0.706; I 2 = 0.0 %, P = 0.940) dizziness/headache (OR = 1.10; 95% CI = 0.44-2.75; P = 0.831; I 2 = 0.0 %, P = 0.882) shivering (OR = 0.95 % CI = 0.50-1.66; P = 0.831; I 2 = 0.0 %, P = 0.920) and dry mouth (OR = 1.00; 95 % CI = 0.50-1.96; P = 0.996; I 2 = 0.0%, P = 0.900). No significant difference was observed in subgroup comparison of adverse events in the intravenous or local adjuvant use of the study drugs (p > 0.05). Conclusion: There is no difference in adverse events associated with the intravenous or local adjuvant use of dexmedetomidine and clonidine in local anesthesia.
Effects of oral clonidine premedication on side effects of intravenous ketamine anesthesia: a randomized, double-blind, placebo-controlled study. [2019]To determine the effects of oral clonidine premedication on hemodynamic changes during the entire course of ketamine anesthesia and incidence of postoperative adverse reactions.
Role of Clonidine as adjuvant to intrathecal bupivacaine in patients undergoing lower abdominal surgery: A randomized control study. [2022]Neuraxial anesthesia greatly expands the anesthesiologist armamentarium, providing alternatives to general anesthesia, especially in the lower abdominal surgeries. Clonidine, an alpha-2 adrenergic agonist, has a variety of actions, including potentiation of effects of local anesthetics. This study was undertaken to assess the degree of sensory and motor block and postoperative analgesia provided by low dose (50 mcg) intrathecal clonidine admixed with bupivacaine.
Clonidine administration during intraoperative monitoring for pediatric scoliosis surgery: Effects on central and peripheral motor responses. [2018]To study the effect of clonidine administrated as a co-analgesic during scoliosis surgery, on the neuromonitoring of spinal motor pathways.