Intrathecal Magnesium for Same-day-surgery (MAGLIDIT)

H

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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