Local Anesthesia With Sedation for Cochlear Implant Surgery (IC)

This study has been completed.

Sponsor:

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 [ Designated as safety issue: Yes ]

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

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 ^ICMJE

Cochlear Implant Surgery

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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 ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients with total deafness

Exclusion Criteria:

children under 18 years old

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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, IPO - IC026

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Rogério Hamerschmidt, Instituto Paranaense de Otorrinolaringologia

Study Sponsor ^ICMJE

Instituto Paranaense de Otorrinolaringologia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rogerio Hamerschmidt

Instituto Paranaense de Otorrinolaringologia

Information Provided By

Instituto Paranaense de Otorrinolaringologia

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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