Transient Neurologic Syndrome Clinical Trial
Official title:
Intrathecal Magnesium Associated to Lidocaine Decreases the Incidence of the Transitory Neurologic Syndrome Following Same-day-surgery
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention