Local Anesthesia With Sedation for Cochlear Implant Surgery (IC)

Tracking Information
First Submitted Date	December 16, 2009
First Posted Date	December 17, 2009
Last Update Posted Date	December 17, 2009
Study Start Date	December 2009
Actual Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: December 16, 2009)	Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation
Original Primary Outcome Measures	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Local Anesthesia With Sedation for Cochlear Implant Surgery
Official Title	Local Anesthesia With Sedation for Cochlear Implant Surgery: 3 Case Report
Brief Summary	ABSTRACT Objectives: The aim of this article is to illustrate the possibility of performing a cochlear implant with local anesthesia and sedation, the anesthesic technique and the advantages of that in comparison to a general anesthesia. Materials and method: The investigators describe two successful surgeries done with local anesthesia, including the neural telemetry and the conditions the patient presented after the surgery, with a very good recovery and no complications during and after the procedure. Key words: local anesthesia, cochlear implant
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	3 adult patients with total deafness
Condition	Cochlear Implant Surgery
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: December 16, 2009)	3
Original Actual Enrollment	Same as current
Actual Study Completion Date	December 2009
Actual Primary Completion Date	December 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: adult patients with total deafness Exclusion Criteria: children under 18 years old
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Brazil
Removed Location Countries
Administrative Information
NCT Number	NCT01033890
Other Study ID Numbers	IC-026; IPO IC 026 ( Registry Identifier: IPO - IC 026 ); IPO - IC026
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Rogério Hamerschmidt, Instituto Paranaense de Otorrinolaringologia
Study Sponsor	Instituto Paranaense de Otorrinolaringologia
Collaborators	Not Provided
Investigators	Principal Investigator: Rogerio Hamerschmidt Instituto Paranaense de Otorrinolaringologia
PRS Account	Instituto Paranaense de Otorrinolaringologia
Verification Date	December 2009