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| Sponsors and Collaborators: |
University Hospital, Clermont-Ferrand University Hospital |
|---|---|
| Information provided by: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT00560092 |
Purpose
Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system [1]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Total Hip Replacement |
Drug: intrathecal magnesium sulfate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Effects of a Single Dose of Intrathecal Magnesium Sulfate on Postoperative Morphine Consumption After Total Hip Replacement |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Magnesium is implicated in the activation of NMDA receptors by amino-excitatory acids in the central nervous system [1]. Magnesium deficiency is associated to an increased activation of these receptors, and to an increased sensitivity to pain in animals. Spinal cord is the site of sensitization of pain, mainly mediated by the NMDA receptors, and intrathecal magnesium may have anti-hyperalgesic effect when administered intrathecally [2]. As intrathecal magnesium has already been used in humans for treatment of eclampsia, we stated that it could also improve postoperative analgesia and reduce the need for auto-administered morphine if given (50 mg of magnesium sulfate) with the intrathecal anesthetic drugs (bupivacaine and sufentanil) injected for orthopedic surgery.
Eligibility| Ages Eligible for Study: | 56 Years to 93 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Christian Duale, Doctor | (33) 04 73 751 590 | cduale@chu-clermontferrand.fr |
| France, Auvergne | |
| Clermont-Ferrand University Hospital | Recruiting |
| Clermont-Ferrand, Auvergne, France, 63000 | |
| Principal Investigator: | Christian Duale, Dr | University Hospital, Clermont-Ferrand |
More Information
| Responsible Party: | CHU Clermont-Ferrand ( Dr Christian DUALE ) |
| Study ID Numbers: | CHU63-006 |
| Study First Received: | June 22, 2006 |
| Last Updated: | October 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00560092 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Magnesium Pain Morphine |
Intrathecal NMDA Elective total hip replacement under intrathecal anesthesia |
|
Calcium, Dietary Morphine Magnesium Sulfate Calcium Channel Blockers Central Nervous System Depressants Anesthetics |
Pain Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Anticonvulsants |
|
Molecular Mechanisms of Pharmacological Action Magnesium Sulfate Physiological Effects of Drugs Calcium Channel Blockers Anesthetics Central Nervous System Depressants Reproductive Control Agents Cardiovascular Agents Pharmacologic Actions |
Membrane Transport Modulators Tocolytic Agents Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |