Cochlear Implant SurgeryICNCT01033890
Local Anesthesia With Sedation for Cochlear Implant Surgery
An observational study of Cochlear Implant Surgery, run by Instituto Paranaense de Otorrinolaringologia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implant Surgery
- How many people
- 3 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3 adult patients with total deafness
Who may be able to join
- adult patients with total deafness
Who cannot join
- children under 18 years old
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Paranaense de Otorrinolaringologia
Curitiba, Paraná, 80620-010
About this study
Official title: Local Anesthesia With Sedation for Cochlear Implant Surgery: 3 Case Report
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
- Conditions
- Cochlear Implant Surgery
- Keywords
- local anesthesia, cochlear implant, sedation, 3 patients submitted to cochlear implant surgery with local anesthesia with sedation
What is being measured
The primary outcome is the main question the study is designed to answer.
Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Implant SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Paranaense de Otorrinolaringologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogerio Hamerschmidt, Instituto Paranaense de Otorrinolaringologia
- Investigators
- Rogerio Hamerschmidt, Principal investigator, Instituto Paranaense de Otorrinolaringologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033890
- Sponsor's protocol ID
- IC-026
- Other IDs
- IPO IC 026, IPO - IC026
- Acronym
- IC
- Status last verified
- Sep 2023
- First submitted
- 16 Dec 2009
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthesia With Sedation for Cochlear Implant Surgery: 3 Case Report
- ClinicalTrials.gov ID
- NCT01033890
- Acronym / sponsor ID
- IC / IC-026
- Conditions
- Cochlear Implant Surgery
- Keywords
- local anesthesia, cochlear implant, sedation, 3 patients submitted to cochlear implant surgery with local anesthesia with sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Instituto Paranaense de OtorrinolaringologiaUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3 adult patients with total deafness
Key inclusion criteria (1 listed)
- adult patients with total deafness
Key exclusion criteria (1 listed)
- children under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rogerio Hamerschmidt principal investigator
Instituto Paranaense de Otorrinolaringologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implant Surgery, run by Instituto Paranaense de Otorrinolaringologia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good liability and pos operative period of the patients submitted to cochlear implant surgery with local anestesia and sedation (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.