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

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
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

No publications provided

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014