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

Sponsor
Federal University of Minas Gerais (Other)
Overall Status
Completed
CT.gov ID
NCT02769390
Collaborator
(none)
80
Enrollment
4
Arms
4
Duration (Months)

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Jul 1, 2015
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Atensine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption [24 hours after the surgery]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Federal University of Minas Gerais

    Investigators

    • Principal Investigator: ana claudia mota bonisson, M, Hospital da Baleia - Fundação Benjamim Guimaraes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Renato Santiago Gomez, PhD, Federal University of Minas Gerais
    ClinicalTrials.gov Identifier:
    NCT02769390
    Other Study ID Numbers:
    • CAAE23332313600005149
    First Posted:
    May 11, 2016
    Last Update Posted:
    May 13, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Renato Santiago Gomez, PhD, Federal University of Minas Gerais
    Analgesia
    Bupivacaine
    Clonidine
    Additional relevant MeSH terms:
    Hypospadias
    Clonidine
    Diazepam

    Study Results

    No Results Posted as of May 13, 2016