Local Anesthesia With Sedation for Cochlear Implant Surgery (IC)

• ClinicalTrials.gov Identifier: NCT01033890
• Recruitment Status: Completed
• First Posted: December 17, 2009
• Last Update Posted: December 17, 2009
• Sponsor: Instituto Paranaense de Otorrinolaringologia
• Information provided by: Instituto Paranaense de Otorrinolaringologia

Tracking Information

• 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 (submitted: December 16, 2009): 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

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: 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: Cochlear Implant Surgery
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 16, 2009): 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:

• adult patients with total deafness

Exclusion Criteria:

• children under 18 years old

Sex/Gender

• Sexes Eligible for Study: All

• 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

Administrative Information

• NCT Number: NCT01033890
• Other Study ID Numbers: IC-026; IPO IC 026 ( Registry Identifier: IPO - IC 026 ); IPO - IC026
• 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

• Principal Investigator: Rogerio Hamerschmidt; Instituto Paranaense de Otorrinolaringologia

• PRS Account: Instituto Paranaense de Otorrinolaringologia
• Verification Date: December 2009