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Spinal Anesthesia Using Lidocaine and Sufentanil and (Transient Neurological Symptoms) TNS

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Britt-Marie Berling, Vestre Viken Ringerike Sykehus.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283087
First Posted: January 25, 2011
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Britt-Marie Berling, Vestre Viken Ringerike Sykehus
  Purpose
The purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms.

Condition
Transient Neurologic Symptoms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Spinal Anesthesia Using Lidocaine and Sufentanil and TNS (=Transient Neurological Symptoms)

Resource links provided by NLM:


Further study details as provided by Britt-Marie Berling, Vestre Viken Ringerike Sykehus:

Primary Outcome Measures:
  • Symptoms of transient neurological symptoms [ Time Frame: 5 days ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are submitted for surgery at a local hospital and where spinal anesthesia is indicated.
Criteria

Inclusion Criteria:

  • adults over the age of eighteen 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283087


Contacts
Contact: Britt-Marie Berling, MD, PhD +4732116000 britt-marie.berling@vestreviken.no

Locations
Norway
Ringerike Sykehus Recruiting
Hønefoss, Norway, No 3501
Contact: Britt-Marie Berling, MD, PhD    +4732116000    britt-marie.berling@vestreviken.no   
Vestre Viken HF Ringerike Sykehus Recruiting
Hønefoss, Norway, NO-3510
Contact: Britt-Marie Berling, MD, PhD    +4732116000    britt-marie.berling@vestreviken.no   
Principal Investigator: Britt-Marie Berling, MD, PhD         
Sponsors and Collaborators
Vestre Viken Ringerike Sykehus
Investigators
Study Chair: halfdan Aas, MD, PhD Vestre Viken HF
Study Chair: halfdan Aas, MD, PhD VestreViken HF
  More Information

Responsible Party: Britt-Marie Berling, MD, PhD, Vestre Viken Ringerike Sykehus
ClinicalTrials.gov Identifier: NCT01283087     History of Changes
Other Study ID Numbers: 400229
First Submitted: January 21, 2011
First Posted: January 25, 2011
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Britt-Marie Berling, Vestre Viken Ringerike Sykehus:
TNS
Spinal anesthesia
Lidocaine

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anesthetics
Lidocaine
Sufentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General