Local Anesthesia With Sedation for Cochlear Implant Surgery (IC)
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ClinicalTrials.gov Identifier: NCT01033890 |
Recruitment Status :
Completed
First Posted : December 17, 2009
Last Update Posted : December 17, 2009
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Sponsor:
Instituto Paranaense de Otorrinolaringologia
Information provided by:
Instituto Paranaense de Otorrinolaringologia
Tracking Information | ||||
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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 |
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 |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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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 |
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PRS Account | Instituto Paranaense de Otorrinolaringologia | |||
Verification Date | December 2009 |