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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

Tracking Information
First Submitted Date  ICMJE April 9, 2015
First Posted Date  ICMJE May 11, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2016)
Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption [ Time Frame: 24 hours after the surgery ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2016)
effective postoperative analgesia [ Time Frame: 24 hours after the procedures ]
comparasion of postoperative analgesia whit different doses of clonidine epidural caudal to hypospadias surgery
Change History Complete list of historical versions of study NCT02769390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
Official Title  ICMJE Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Clonidine 1 mcg/Kg
  • 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
    Intervention: Drug: Clonidine 2 mcg/ Kg
  • 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
    Intervention: Drug: Clonidine 3 mcg/ Kg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2016)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 1 Year to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02769390
Other Study ID Numbers  ICMJE CAAE23332313600005149
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Renato Santiago Gomez, Federal University of Minas Gerais
Study Sponsor  ICMJE Federal University of Minas Gerais
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ana claudia mota bonisson, M Hospital da Baleia - Fundação Benjamim Guimaraes
PRS Account Federal University of Minas Gerais
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP