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Transient Neurologic SyndromePhase 3MAGLIDITNCT01794247

Intrathecal Magnesium for Same-day-surgery

A Phase 3 study testing Magnesium sulfate, Fentanyl and Lidocaine in people with Transient Neurologic Syndrome, run by Hospital General de Ciudad Real at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Transient Neurologic Syndrome
What is being tested?
Magnesium sulfate, Fentanyl and Lidocaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesSpain
Study dates
Apr 2013to Mar 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Same day surgery patients
  • Operated in lithotomy or arthroscopy position or obese patients

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital General universitario de Ciudad Real

    Ciudad Real, Castille-La Mancha, 13005

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, Ciudad Real, 13170

Other trials in Spain

About this study

Official title: Intrathecal Magnesium Associated to Lidocaine Decreases the Incidence of the Transitory Neurologic Syndrome Following Same-day-surgery

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.

Being tested
Magnesium sulfate, Fentanyl, Lidocaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01794247
Study groupRoleWhat they receive
Intrathecal magnesiumExperimentalIntrathecal magnesium sulfate 15% 0,5 mL (75 mg) is added to lidocaine 5% 1 mL (50 mg)as anesthetic adjuvant
Receives: Drug: Magnesium sulfate; Drug: Lidocaine
Intrathecal fentanylActive comparatorIntrathecal fentanyl 0.5 mL (25 micrograms)is added to lidocaine 5% 1 ML (50 mg) as anesthetic adjuvant
Receives: Drug: Fentanyl; Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transient Neurologic Syndrome Incidence

    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.

    Measured: 7 postoperative days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2013
  4. Study completionMar 2014

Why it stopped: low recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01794247
Sponsor's protocol ID
MAGLIDIT-12
Other IDs
2012-004538-40
Acronym
MAGLIDIT
Status last verified
Mar 2014
First submitted
15 Feb 2013
Last updated
10 Mar 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Jabalameli M, Pakzadmoghadam SH. Adding different doses of intrathecal magnesium sulfate for spinal anesthesia in the cesarean section: A prospective double blind randomized trial. Adv Biomed Res. 2012;1:7. doi: 10.4103/2277-9175.94430. Epub 2012 May 11.

    PubMed 23210066

  • Nath MP, Garg R, Talukdar T, Choudhary D, Chakrabarty A. To evaluate the efficacy of intrathecal magnesium sulphate for hysterectomy under subarachnoid block with bupivacaine and fentanyl: A prospective randomized double blind clinical trial. Saudi J Anaesth. 2012 Jul;6(3):254-8. doi: 10.4103/1658-354X.101217.

    PubMed 23162399

  • Khezri MB, Yaghobi S, Hajikhani M, Asefzadeh S. Comparison of postoperative analgesic effect of intrathecal magnesium and fentanyl added to bupivacaine in patients undergoing lower limb orthopedic surgery. Acta Anaesthesiol Taiwan. 2012 Mar;50(1):19-24. doi: 10.1016/j.aat.2012.03.001. Epub 2012 Mar 31.

    PubMed 22500909

  • Shukla D, Verma A, Agarwal A, Pandey HD, Tyagi C. Comparative study of intrathecal dexmedetomidine with intrathecal magnesium sulfate used as adjuvants to bupivacaine. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):495-9. doi: 10.4103/0970-9185.86594.

    PubMed 22096283

  • Khalili G, Janghorbani M, Sajedi P, Ahmadi G. Effects of adjunct intrathecal magnesium sulfate to bupivacaine for spinal anesthesia: a randomized, double-blind trial in patients undergoing lower extremity surgery. J Anesth. 2011 Dec;25(6):892-7. doi: 10.1007/s00540-011-1227-z. Epub 2011 Sep 18.

    PubMed 21928127

  • Mebazaa MS, Ouerghi S, Frikha N, Moncer K, Mestiri T, James MF, Ben Ammar MS. Is magnesium sulfate by the intrathecal route efficient and safe? Ann Fr Anesth Reanim. 2011 Jan;30(1):47-50. doi: 10.1016/j.annfar.2010.12.005. Epub 2011 Jan 13.

    PubMed 21236623

  • Ouerghi S, Fnaeich F, Frikha N, Mestiri T, Merghli A, Mebazaa MS, Kilani T, Ben Ammar MS. The effect of adding intrathecal magnesium sulphate to morphine-fentanyl spinal analgesia after thoracic surgery. A prospective, double-blind, placebo-controlled research study. Ann Fr Anesth Reanim. 2011 Jan;30(1):25-30. doi: 10.1016/j.annfar.2010.10.018. Epub 2010 Dec 8.

    PubMed 21145193

  • Malleeswaran S, Panda N, Mathew P, Bagga R. A randomised study of magnesium sulphate as an adjuvant to intrathecal bupivacaine in patients with mild preeclampsia undergoing caesarean section. Int J Obstet Anesth. 2010 Apr;19(2):161-6. doi: 10.1016/j.ijoa.2009.08.007. Epub 2010 Feb 18.

    PubMed 20171080

  • Ghrab BE, Maatoug M, Kallel N, Khemakhem K, Chaari M, Kolsi K, Karoui A. [Does combination of intrathecal magnesium sulfate and morphine improve postcaesarean section analgesia?]. Ann Fr Anesth Reanim. 2009 May;28(5):454-9. doi: 10.1016/j.annfar.2009.03.004. Epub 2009 May 7. French.

    PubMed 19427159

  • Unlugenc H, Ozalevli M, Gunduz M, Gunasti S, Urunsak IF, Guler T, Isik G. Comparison of intrathecal magnesium, fentanyl, or placebo combined with bupivacaine 0.5% for parturients undergoing elective cesarean delivery. Acta Anaesthesiol Scand. 2009 Mar;53(3):346-53. doi: 10.1111/j.1399-6576.2008.01864.x. Epub 2009 Jan 23.

    PubMed 19173689

  • Jellish WS, Zhang X, Langen KE, Spector MS, Scalfani MT, White FA. Intrathecal magnesium sulfate administration at the time of experimental ischemia improves neurological functioning by reducing acute and delayed loss of motor neurons in the spinal cord. Anesthesiology. 2008 Jan;108(1):78-86. doi: 10.1097/01.anes.0000296109.04010.82.

    PubMed 18156885

  • Arcioni R, Palmisani S, Tigano S, Santorsola C, Sauli V, Romano S, Mercieri M, Masciangelo R, De Blasi RA, Pinto G. Combined intrathecal and epidural magnesium sulfate supplementation of spinal anesthesia to reduce post-operative analgesic requirements: a prospective, randomized, double-blind, controlled trial in patients undergoing major orthopedic surgery. Acta Anaesthesiol Scand. 2007 Apr;51(4):482-9. doi: 10.1111/j.1399-6576.2007.01263.x.

    PubMed 17378788

  • Ozalevli M, Cetin TO, Unlugenc H, Guler T, Isik G. The effect of adding intrathecal magnesium sulphate to bupivacaine-fentanyl spinal anaesthesia. Acta Anaesthesiol Scand. 2005 Nov;49(10):1514-9. doi: 10.1111/j.1399-6576.2005.00793.x.

    PubMed 16223399

  • Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents. doi: 10.1097/00000539-200209000-00031.

    PubMed 12198056

  • Saeki H, Matsumoto M, Kaneko S, Tsuruta S, Cui YJ, Ohtake K, Ishida K, Sakabe T. Is intrathecal magnesium sulfate safe and protective against ischemic spinal cord injury in rabbits? Anesth Analg. 2004 Dec;99(6):1805-1812. doi: 10.1213/01.ANE.0000138039.04548.3D.

    PubMed 15562076

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Magnesium sulfate, Fentanyl and Lidocaine in people with Transient Neurologic Syndrome, run by Hospital General de Ciudad Real at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transient Neurologic Syndrome Incidence (time frame: 7 postoperative days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01794247, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2014.

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