Clinical trial NCT01794247: Intrathecal Magnesium for Same-day-surgery
Official title: Intrathecal Magnesium Associated to Lidocaine Decreases the Incidence of the Transitory Neurologic Syndrome Following Same-day-surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Transient Neurologic Syndrome
Lead sponsor: Hospital General de Ciudad Real
Sponsor class: OTHER
Collaborators: name: University of Castilla-La Mancha
First posted: 2013-02-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Transient Neurologic Syndrome Incidence
timeFrame: 7 postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad Real
country: Spain
facility: Hospital General universitario de Ciudad Real
state: Castilla-La Mancha
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
Study officials:
affiliation: Hospital general Universitario de Ciudad Real
name: Javier Pascual-Ramírez, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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