Intrathecal Magnesium for Same-day-surgery

Study Overview
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Brief Summary
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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.

Official Title
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Intrathecal Magnesium Associated to Lidocaine Decreases the Incidence of the Transitory Neurologic Syndrome Following Same-day-surgery

Conditions
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Transient Neurologic Syndrome

Intervention / Treatment
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* Drug: Magnesium sulfate
* Drug: Fentanyl
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrathecal magnesium<br>Intrathecal magnesium sulfate 15% 0,5 mL (75 mg) is added to lidocaine 5% 1 mL (50 mg)as anesthetic adjuvant | Drug: Magnesium sulfate<br> <br> Drug: Lidocaine<br> <br> |
| Active Comparator: Intrathecal fentanyl<br>Intrathecal fentanyl 0.5 mL (25 micrograms)is added to lidocaine 5% 1 ML (50 mg) as anesthetic adjuvant | Drug: Fentanyl<br> <br> Drug: Lidocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |