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

Purpose

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

Condition
Cochlear Implant Surgery


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Local Anesthesia With Sedation for Cochlear Implant Surgery: 3 Case Report

Resource links provided by NLM:

MedlinePlus related topics: Cochlear Implants

U.S. FDA Resources

Further study details as provided by Instituto Paranaense de Otorrinolaringologia:

Primary Outcome Measures:

Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation [ Designated as safety issue: Yes ]


Enrollment:	3
Study Start Date:	December 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

3 adult patients with total deafness

Criteria

Inclusion Criteria:

adult patients with total deafness

Exclusion Criteria:

children under 18 years old

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01033890

Locations


Brazil
Instituto Paranaense de Otorrinolaringologia
Curitiba, PR, Brazil, 80620-010

Sponsors and Collaborators

Instituto Paranaense de Otorrinolaringologia

Investigators


Principal Investigator:	Rogerio Hamerschmidt	Instituto Paranaense de Otorrinolaringologia

More Information


Responsible Party:	Rogério Hamerschmidt, Instituto Paranaense de Otorrinolaringologia
ClinicalTrials.gov Identifier:	NCT01033890 History of Changes
Other Study ID Numbers:	IC-026 IPO IC 026 IPO - IC026
Study First Received:	December 16, 2009
Last Updated:	December 16, 2009
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Paranaense de Otorrinolaringologia:


local anesthesia cochlear implant sedation 3 patients submitted to cochlear implant surgery with local anesthesia with sedation

Additional relevant MeSH terms:


Anesthetics Central Nervous System Depressants Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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