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Local Anesthesia With Sedation for Cochlear Implant Surgery (IC)
This study has been completed.
Sponsor:
Instituto Paranaense de Otorrinolaringologia
Information provided by:
Instituto Paranaense de Otorrinolaringologia
ClinicalTrials.gov Identifier:
NCT01033890
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | December 16, 2009 | |||
| Last Updated Date | December 16, 2009 | |||
| Start Date ICMJE | December 2009 | |||
| Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | No Changes Posted | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Local Anesthesia With Sedation for Cochlear Implant Surgery | |||
| Official Title ICMJE | 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 ICMJE | Observational | |||
| Study Design ICMJE | 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 ICMJE | Cochlear Implant Surgery | |||
| Intervention ICMJE | Not Provided | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
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* 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 ICMJE | Completed | |||
| Enrollment ICMJE | 3 | |||
| Completion Date | December 2009 | |||
| Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Brazil | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01033890 | |||
| Other Study ID Numbers ICMJE | 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 ICMJE | Instituto Paranaense de Otorrinolaringologia | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Instituto Paranaense de Otorrinolaringologia | |||
| Verification Date | December 2009 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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