MAGLIDIT: Intrathecal Magnesium for Same-day-surgery

Sponsor

Hospital General de Ciudad Real (Other)

Overall Status

Terminated

CT.gov ID

NCT01794247

Collaborator

University of Castilla-La Mancha (Other)

Enrollment

Locations

Arms

Duration (Months)

10.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Apr 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Transient Neurologic Syndrome Incidence [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital General universitario de Ciudad Real	Ciudad Real	Castilla-La Mancha	Spain	13005
2	Hospital General Universitario de Ciudad Real	Ciudad Real		Spain	13170

Sponsors and Collaborators

Hospital General de Ciudad Real
University of Castilla-La Mancha

Investigators

Principal Investigator: Javier Pascual-Ramírez, Md, PhD, Hospital general Universitario de Ciudad Real

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Javier Pascual-Ramirez, MD, PhD, Hospital General de Ciudad Real

ClinicalTrials.gov Identifier:

NCT01794247

Other Study ID Numbers:

MAGLIDIT-12
2012-004538-40

First Posted:

Feb 18, 2013

Last Update Posted:

Mar 10, 2014

Last Verified:

Mar 1, 2014

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2014