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Intrathecal Magnesium for Same-day-surgery (MAGLIDIT)

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ClinicalTrials.gov Identifier: NCT01794247
Recruitment Status : Terminated (low recruitment rate)
First Posted : February 18, 2013
Last Update Posted : March 10, 2014
Sponsor:
Collaborator:
University of Castilla-La Mancha
Information provided by (Responsible Party):
Javier Pascual-Ramirez, Hospital General de Ciudad Real

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.


Condition or disease Intervention/treatment Phase
Transient Neurologic Syndrome Drug: Magnesium sulfate Drug: Fentanyl Drug: Lidocaine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Intrathecal Magnesium Associated to Lidocaine Decreases the Incidence of the Transitory Neurologic Syndrome Following Same-day-surgery
Study Start Date : April 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Transient Neurologic Syndrome Incidence [ Time Frame: 7 postoperative days ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794247


Locations
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Spain
Hospital General universitario de Ciudad Real
Ciudad Real, Castilla-La Mancha, Spain, 13005
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain, 13170
Sponsors and Collaborators
Hospital General de Ciudad Real
University of Castilla-La Mancha
Investigators
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Principal Investigator: Javier Pascual-Ramírez, Md, PhD Hospital general Universitario de Ciudad Real

Publications:

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Responsible Party: Javier Pascual-Ramirez, MD, PhD, Hospital General de Ciudad Real
ClinicalTrials.gov Identifier: NCT01794247     History of Changes
Other Study ID Numbers: MAGLIDIT-12
2012-004538-40 ( EudraCT Number )
First Posted: February 18, 2013    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Magnesium Sulfate
Syndrome
Disease
Pathologic Processes
Lidocaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anticonvulsants
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents