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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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
Active Comparator: Intrathecal fentanyl
Intrathecal fentanyl 0.5 mL (25 micrograms)is added to lidocaine 5% 1 ML (50 mg) as anesthetic adjuvant
- 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.
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
|Hospital General universitario de Ciudad Real|
|Ciudad Real, Castilla-La Mancha, Spain, 13005|
|Hospital General Universitario de Ciudad Real|
|Ciudad Real, Spain, 13170|
|Principal Investigator:||Javier Pascual-Ramírez, Md, PhD||Hospital general Universitario de Ciudad Real|