Transient Neurologic Syndrome Clinical Trial
— MAGLIDITOfficial title:
Intrathecal Magnesium Associated to Lidocaine Decreases the Incidence of the Transitory Neurologic Syndrome Following Same-day-surgery
| Verified date | March 2014 |
| Source | Hospital General de Ciudad Real |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Spanish Agency of Medicines |
| Study type | Interventional |
5% hyperbaric lidocaine has lost its usefulness for same-day-surgery (SDS) anaesthesia
because it has been blamed responsible for the so-called transitory neurological syndrome
(TNS). This entity appears particularly in patients operated on lithotomy and knee
arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out
of 10) and self-limited in time, but disturbing enough to be avoided in same-day-surgery
cases. Other local anesthetics are not competitive with general anesthesia in time to be
discharged home from the SDS unit. The magnesium ion is well-known for its protective
properties on cells with electrical activity. The objective is to confirm that the magnesium
ion added as adjuvant to intrathecal (IT) lidocaine may antagonize TNS incidence. If this
hypothesis could be confirmed, the practical and theoretical consequences would be
far-reaching.
The method to achieve our objective would be a double-blinded randomized clinical trial
considering two groups of intrathecal lidocaine: with and without added IT magnesium.
| Status | Terminated |
| Enrollment | 21 |
| Est. completion date | March 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Same day surgery patients - Operated in lithotomy or arthroscopy position or obese patients Exclusion Criteria: - American Society of Anesthesia 3 or 4 patients - Younger than 18 or elder than 80 years-old - Active lumbar pain - Any short of chronic neurologic disease - Any short of myopathy - Pregnant women - Previous history of allergic or toxic reaction to lidocaine, magnesium or fentanyl |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital General universitario de Ciudad Real | Ciudad Real | Castilla-La Mancha |
| Spain | Hospital General Universitario de Ciudad Real | Ciudad Real |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital General de Ciudad Real | University of Castilla-La Mancha |
Spain,
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Transient Neurologic Syndrome Incidence | Transitory neurological syndrome appears particularly in patients operated on lithotomy and knee arthroscopy position and obese patients. It is a benign, moderately painful (grade 3-4 out of 10) buttocks-legs pain, self-limited in time, but disturbing enough to be avoided in same-day-surgery cases. | 7 postoperative days | Yes |