Assessment of Hemodynamic Response in Surgery of Circumci... | NCT00943475

Studies
Assessment of Hemodynamic Response in Surgery of Circumcision in Children

NCT00943475

Sponsor

Federal University of Juiz de Fora

Status

Completed

Last Update Posted

Jul 22, 2009Estimated

Enrollment

40Actual

Phase

Phase 4

Conditions

Children Who Need Circumcision

Interventions

circumcision

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Mar 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jul 21, 2009

First Submission Date that Met QC Criteria

Jul 21, 2009

First Posted Date

Jul 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2009

Last Update Posted Date

Jul 22, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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®.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
anaesthesia, circumcision	Active Comparator		Procedure: circumcision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
circumcision	Procedure	circumcision by plastbell	anaesthesia, circumcision

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA status physical 1 children between 3 and 13 years old

Exclusion Criteria:

parents don't accept the study classic circumcision

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose murillo B Netto, Doctor	Federal University of Juiz de Fora	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
federal University of Juiz de Fora		Juiz de Fora	Minas Gerais	36036-900	Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8010422	Result	Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31. doi: 10.1213/00000539-199407000-00024.
12538184	Result	Choi WY, Irwin MG, Hui TW, Lim HH, Chan KL. EMLA cream versus dorsal penile nerve block for postcircumcision analgesia in children. Anesth Analg. 2003 Feb;96(2):396-9, table of contents. doi: 10.1097/00000539-200302000-00018.

Type	Date	Date Unknown
Release	Apr 25, 2012
Reset	May 23, 2012
Release	Sep 6, 2012
Reset	Oct 4, 2012
Release	Feb 22, 2013
Reset	Mar 29, 2013
Release	Mar 10, 2017
Reset	Apr 20, 2017

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 25, 2012			May 23, 2012
Sep 6, 2012

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D046289	Body Modification, Non-Therapeutic
D003357	Cosmetic Techniques
D013812	Therapeutics
D013514	Surgical Procedures, Operative