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Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery (clonidine)

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ClinicalTrials.gov Identifier: NCT02769390
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Renato Santiago Gomez, Federal University of Minas Gerais

Brief Summary:

The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Clonidine 1 mcg/Kg Drug: Clonidine 2 mcg/ Kg Drug: Clonidine 3 mcg/ Kg Phase 2

Detailed Description:
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. Postoperative hemodynamics parameters will be recordes at 24 h.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
Study Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Bupivacaine 0,166%
General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% for hypospadia surgery
Active Comparator: Clonidine 1 mcg/Kg
IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery
Drug: Clonidine 1 mcg/Kg
Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Other Name: Atensine

Active Comparator: Clonidine 2 mcg/ Kg
IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery
Drug: Clonidine 2 mcg/ Kg
Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
Other Name: Atensine

Active Comparator: Clonidine 3 mcg/Kg
General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery
Drug: 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 Name: Atensine




Primary Outcome Measures :
  1. Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption [ Time Frame: 24 hours after the surgery ]


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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CHildren 1 - 10 years old.
  • ASA I E II ( American Society of Anesthesiology)
  • hypospadias surgery

Exclusion Criteria:

  • parents refuse
  • Infection
  • Coagulation disorders
  • Allergy to anesthetics
  • Abnormalities of the sacral spine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769390


Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Principal Investigator: ana claudia mota bonisson, M Hospital da Baleia - Fundação Benjamim Guimaraes

Publications:
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Responsible Party: Renato Santiago Gomez, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02769390     History of Changes
Other Study ID Numbers: CAAE23332313600005149
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Renato Santiago Gomez, Federal University of Minas Gerais:
Analgesia
Bupivacaine
Clonidine
Additional relevant MeSH terms:
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Clonidine
Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Diazepam
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anticonvulsants
Antiemetics
Gastrointestinal Agents
Hypnotics and Sedatives
Muscle Relaxants, Central