- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07418580
Magnesium Sulfate Infusion on Postoperative Pain in Lumbar Surgery
The Effects of Perioperative Low-dose Magnesium Sulfate Infusion on Postoperative Pain in Lumbar Surgery
Effective postoperative analgesia after lumbar spine surgery (e.g., laminectomy, vertebroplasty, lumbar stabilization) is associated with faster recovery and shorter hospital stay. Multimodal analgesia aims to reduce opioid consumption and related adverse effects by combining agents with complementary mechanisms of action at peripheral and central levels.
Magnesium is one of the agents used in this approach. Its analgesic effects are attributed to inhibition of neuropathic pain, potentiation of opioid analgesia, and attenuation of opioid tolerance. Mechanistically, magnesium acts as a non-competitive NMDA receptor antagonist and modulates intracellular calcium influx, thereby reducing central glutamate release and limiting hyperalgesia.
However, the clinical efficacy of perioperative magnesium remains controversial. Outcomes may vary depending on timing (intraoperative vs. postoperative), dosing strategies (bolus vs. infusion), and total administered dose. The optimal dosage, administration method, safety profile, and dose-response relationship of magnesium for analgesic purposes are not yet clearly established.
This study aims to evaluate the effectiveness of perioperative low-dose magnesium sulfate (MgSO₄) in this context.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye), 34371
- Sisli etfal research and training hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 18 years and older,
- ASA (American Society of Anesthesiologists) physical status I-II,
- awaiting to undergo lumbar spinal surgery under general anesthesia.
Exclusion Criteria:
- the presence of cardiac conduction disorders and/or cardiac comorbidities
- use of Ca channel blockers,
- hepatic/renal failure and allergy to Mg.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: the magnesium treatment group (Group M)
Initial serum magnesium levels of the patients were measured at the beginning of the surgery; and subsequently an infusion of MgSO4 (10 mg/kg/h) in 100 mL of normal saline (NS) was initiated in groups M, respectively.
|
Initial serum magnesium levels of the patients were measured at the beginning of the surgery; and subsequently an infusion of MgSO4 (10 mg/kg/h) in 100 mL of normal saline (NS) was initiated in groups C, respectively.
|
|
Active Comparator: the control group (Group C)
Initial serum magnesium levels of the patients were measured at the beginning of the surgery; and subsequently an infusion of and an infusion of 100 mL of NS (10 mg/kg/h) was initiated in groups C, respectively.
|
Initial serum magnesium levels of the patients were measured at the beginning of the surgery; and subsequently an infusion of 100 mL of NS (10 mg/kg/h) was initiated in groups m, respectively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual analog scale
Time Frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.
|
The Visual Analog Scale (VAS) is a unidimensional tool used to measure pain intensity.
It typically consists of a 10-cm horizontal line ranging from "no pain" (0) to "worst imaginable pain" (10), on which patients mark the point that best represents their perceived pain level.
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It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Richmond Agitation-Sedation Scale.
Time Frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.
|
The Richmond Agitation-Sedation Scale (RASS) is a validated clinical tool used to assess the level of agitation and sedation in hospitalized patients, particularly in intensive care settings.
It ranges from +4 (combative) to -5 (unarousable), allowing clinicians to monitor and titrate sedative and analgesic therapy effectively.
|
It will be measured at the 0th, 1st, 2nd, 3rd, 4th, and 5th hours.
|
|
heart rate
Time Frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
|
heart rate will recorded in the peri-operative period.
|
It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
|
|
sistolic blood pressure
Time Frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
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sistolic blood pressure will recorded in the peri-operative period as mmhg.
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It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
|
|
diastolic blood pressure
Time Frame: It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
|
diastolic blood pressure will recorded in the peri-operative period as mmhg.
|
It will be measured at the 0th, 1st, 2nd, 3rd, 4th, 5th, and 6th hours in the peri-operative period
|
Collaborators and Investigators
Investigators
- Study Chair: sibel oba, şişli etfal eğitim araştırma hastanesi
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Pain, Postoperative
- Sulfur Compounds
- Pharmaceutical Preparations
- Inorganic Chemicals
- Crystalloid Solutions
- Isotonic Solutions
- Solutions
- Sulfur Acids
- Sulfates
- Sulfuric Acids
- Magnesium Compounds
- Magnesium Sulfate
- Saline Solution
Other Study ID Numbers
- salkaya-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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