Assessment of Hemodynamic Response in Surgery of Circumcision in Children

July 21, 2009 updated by: Federal University of Juiz de Fora

Assessment of Hemodynamic Response and Pos-operatory Pain in Surgery of Circumcision in Children

The surgery stress relives systemic inflammatory response by hormones and adrenergic receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the physiologic status is impaired and the patient is more susceptible an infection and cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved more safety to the patient.

This study is a double blind controlled trial with 40 patients divided in two groups (EMLA and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory rate, arterial pressure, involuntary movements during the surgery and pain in the pos-operatory.

With this study, the investigators can define what tactic (EMLA or DPNB) associated a general anesthesia is more effective to relive the pain when children are submitted a postectomy by Plastbell®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas gerais
      • Juiz de Fora, Minas gerais, Brazil, 36036-900
        • Federal University of Juiz de Fora

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

ASA status physical 1 children between 3 and 13 years old

Exclusion Criteria:

  • parents don't accept the study classic circumcision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: anaesthesia, circumcision
Procedure: circumcision
circumcision by plastbell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
local anesthesia relieve the circumcision pain
Time Frame: per-operatory; 1h and 24h pos-operatory
per-operatory; 1h and 24h pos-operatory

Secondary Outcome Measures

Outcome Measure
Time Frame
local anesthesia relieve the circumcision pos-operatory pain
Time Frame: 1h and 24h pos-operatory
1h and 24h pos-operatory

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Juiz de Fora

Investigators

  • Principal Investigator: Jose murillo B Netto, Doctor, Federal University of Juiz de Fora

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

July 21, 2009

First Submitted That Met QC Criteria

July 21, 2009

First Posted (ESTIMATE)

July 22, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2009

Last Update Submitted That Met QC Criteria

July 21, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAAE:0101.0.180.000-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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