Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
NCT ID: NCT02769390
Last Updated: 2016-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2015-07-31
2015-11-30
Brief Summary
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It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Bupivacaine 0,166%
General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery
No interventions assigned to this group
Clonidine 1 mcg/Kg
IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery
Clonidine 1 mcg/Kg
Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Clonidine 2 mcg/ Kg
IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery
Clonidine 2 mcg/ Kg
Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Clonidine 3 mcg/Kg
General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery
Clonidine 3 mcg/ Kg
Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Interventions
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Clonidine 1 mcg/Kg
Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Clonidine 2 mcg/ Kg
Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Clonidine 3 mcg/ Kg
Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA I E II ( American Society of Anesthesiology)
* hypospadias surgery
Exclusion Criteria
* Infection
* Coagulation disorders
* Allergy to anesthetics
* Abnormalities of the sacral spine
1 Year
10 Years
MALE
No
Sponsors
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Federal University of Minas Gerais
OTHER
Responsible Party
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Renato Santiago Gomez
PhD
Principal Investigators
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ana claudia mota bonisson, M
Role: PRINCIPAL_INVESTIGATOR
Hospital da Baleia - Fundação Benjamim Guimaraes
References
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Fernandes ML, Pires KC, Tiburcio MA, Gomez RS. Caudal bupivacaine supplemented with morphine or clonidine, or supplemented with morphine plus clonidine in children undergoing infra-umbilical urological and genital procedures: a prospective, randomized and double-blind study. J Anesth. 2012 Apr;26(2):213-8. doi: 10.1007/s00540-011-1297-y. Epub 2011 Dec 10.
Mauch J, Weiss M. [Pediatric caudal anesthesia: importance and aspects of safety concerns]. Schmerz. 2012 Aug;26(4):443-53; quiz 454. doi: 10.1007/s00482-012-1202-0. German.
Other Identifiers
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CAAE23332313600005149
Identifier Type: -
Identifier Source: org_study_id
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