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Local Anesthesia With Sedation for Cochlear Implant Surgery (IC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01033890
Recruitment Status : Completed
First Posted : December 17, 2009
Last Update Posted : December 17, 2009
Sponsor:
Information provided by:
Instituto Paranaense de Otorrinolaringologia

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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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, Older Adult)
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