Intrathecal Magnesium for Same-day-surgery (MAGLIDIT)

Hospital General de Ciudad Real

Status and phase: Terminated; Phase 3

Conditions: Transient Neurologic Syndrome

Treatments: Drug: Lidocaine; Drug: Magnesium sulfate; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT01794247

MAGLIDIT-12

2012-004538-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups

Intrathecal magnesium

Experimental group

Description:

Intrathecal magnesium sulfate 15% 0,5 mL (75 mg) is added to lidocaine 5% 1 mL (50 mg)as anesthetic adjuvant

Treatment:

Drug: Lidocaine

Drug: Magnesium sulfate

Intrathecal fentanyl

Active Comparator group

Description:

Intrathecal fentanyl 0.5 mL (25 micrograms)is added to lidocaine 5% 1 ML (50 mg) as anesthetic adjuvant

Treatment:

Drug: Fentanyl

Drug: Lidocaine