- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01283087
Spinal Anesthesia Using Lidocaine and Sufentanil and (Transient Neurological Symptoms) TNS
November 23, 2017 updated by: Britt-Marie Berling, Vestre Viken Ringerike Sykehus
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
168
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hønefoss, Norway, No 3501
- Ringerike Sykehus
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Hønefoss, Norway, NO-3510
- Vestre Viken HF Ringerike Sykehus
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who are submitted for surgery at a local hospital and where spinal anesthesia is indicated.
Description
Inclusion Criteria:
- adults over the age of seventeen years
Exclusion Criteria:
- patient refuse spinal anesthesia
- spinal anesthesia is contraindicated
- pregnancy
- patient is incapable of giving consent
- diabetes
- neurological disorders
- chronic pain
- chronic use of analgesics
- spinal anesthesia within five days before the actual surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptoms of transient neurological symptoms
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: halfdan Aas, MD, PhD, Vestre Viken HF
- Study Chair: halfdan Aas, MD, PhD, VestreViken HF
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ACTUAL)
May 1, 2016
Study Registration Dates
First Submitted
January 21, 2011
First Submitted That Met QC Criteria
January 24, 2011
First Posted (ESTIMATE)
January 25, 2011
Study Record Updates
Last Update Posted (ACTUAL)
November 27, 2017
Last Update Submitted That Met QC Criteria
November 23, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 400229
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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