Local Anesthesia With Sedation for Cochlear Implant Surgery | NCT01033890

Studies
Local Anesthesia With Sedation for Cochlear Implant Surgery

NCT01033890

Sponsor

Instituto Paranaense de Otorrinolaringologia

Status

Completed

Last Update Posted

Sep 28, 2023Actual

Enrollment

3Actual

Phase

Not provided

Conditions

Cochlear Implant Surgery

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IPO IC 026	Registry Identifier	IPO - IC 026
IPO - IC026

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Dec 16, 2009

First Submission Date that Met QC Criteria

Dec 16, 2009

First Posted Date

Dec 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2023

Last Update Posted Date

Sep 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rogerio Hamerschmidt, Professor, Instituto Paranaense de OtorrinolaringologiaPrincipal Investigator

Lead Sponsor

Instituto Paranaense de OtorrinolaringologiaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation		one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients with total deafness

Exclusion Criteria:

children under 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

3 adult patients with total deafness

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rogerio Hamerschmidt	Instituto Paranaense de Otorrinolaringologia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Paranaense de Otorrinolaringologia		Curitiba	Paraná	80620-010	Brazil