Transient Neurologic SymptomsNCT01283087
Spinal Anesthesia Using Lidocaine and Sufentanil and (Transient Neurological Symptoms) TNS
An observational study of Transient Neurologic Symptoms, run by Vestre Viken Ringerike Sykehus at 2 sites in Norway.
Trial summary
The purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Neurologic Symptoms
- How many people
- 168 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2011to May 2016
- 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: Patients who are submitted for surgery at a local hospital and where spinal anesthesia is indicated.
Who may be able to join
- adults over the age of seventeen years
Who cannot join
- patient refuse spinal anesthesia
- spinal anesthesia is contraindicated
- pregnancy
- patient is incapable of giving consent
- diabetes
- neurological disorders
Show all 9Show fewer
- chronic pain
- chronic use of analgesics
- spinal anesthesia within five days before the actual surgery
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Ringerike Sykehus
Hønefoss, No 3501
Vestre Viken HF Ringerike Sykehus
Hønefoss, NO-3510
About this study
Official title: Spinal Anesthesia Using Lidocaine and Sufentanil and TNS (=Transient Neurological Symptoms)
The purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms.
- Conditions
- Transient Neurologic Symptoms
- Keywords
- TNS, Spinal anesthesia, Lidocaine
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of transient neurological symptoms
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transient Neurologic SymptomsStudies 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vestre Viken Ringerike Sykehus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britt-Marie Berling, Vestre Viken Ringerike Sykehus
- Investigators
- halfdan Aas, MD, PhD, Study chair, Vestre Viken HFhalfdan Aas, MD, PhD, Study chair, VestreViken HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283087
- Sponsor's protocol ID
- 400229
- Status last verified
- Nov 2017
- First submitted
- 21 Jan 2011
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia Using Lidocaine and Sufentanil and TNS (=Transient Neurological Symptoms)
- ClinicalTrials.gov ID
- NCT01283087
- Acronym / sponsor ID
- 400229
- Conditions
- Transient Neurologic Symptoms
- Keywords
- TNS, Spinal anesthesia, Lidocaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Vestre Viken Ringerike SykehusUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Jan 2011 (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.
The purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms.
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
- Patients who are submitted for surgery at a local hospital and where spinal anesthesia is indicated.
Key inclusion criteria (1 listed)
- adults over the age of seventeen years
Key exclusion criteria (9 listed)
- patient refuse spinal anesthesia
- spinal anesthesia is contraindicated
- pregnancy
- patient is incapable of giving consent
- diabetes
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
Symptoms of transient neurological symptoms
Time frame: 5 days
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 27 Nov 2017.
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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.
halfdan Aas, MD, PhD study chair
Vestre Viken HF
halfdan Aas, MD, PhD study chair
VestreViken HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Neurologic Symptoms, run by Vestre Viken Ringerike Sykehus at 2 sites in Norway.
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 9 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 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Symptoms of transient neurological symptoms (time frame: 5 days). 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 27 Nov 2017.