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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04161729
Other study ID # SpiMag
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 28, 2020
Est. completion date May 5, 2020

Study information

Verified date May 2020
Source Aristotle University Of Thessaloniki
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The treatment of postoperative pain is increasingly based on a multimodal approach and although opioids remain the drug of choice, they are often used in combination with other analgesics (paracetamol, cyclooxygenase inhibitors or non-steroidal anti-inflammatory drugs) and co-analgesic agents (clonidine and anti- NMDA such as ketamine or MgSO4). The rationale for combined analgesia is to achieve additive or synergistic analgesic properties while decreasing the incidence of side effects by reducing the dose of each agent. Nociceptive stimuli are known to activate the release of the excitatory amino acid glutamate in the dorsal horn of the spinal cord. The resultant activation of NMDA receptors causes calcium entry into the cell and triggers central sensitisation. This mechanism is involved in the perception of pain and mainly accounts for its persistence during the postoperative period.

Although magnesium is not a primary analgesic in itself, it enhances the analgesic actions of more established analgesics as an adjuvant agent. Magnesium produces a voltage-dependent block of NMDA receptors and has been reported to have analgesic properties that might be related to this inhibiting property. Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic and endocrine reflexes provoked by noxious stimuli.

When magnesium was used intraoperatively, many researchers reported that it reduced the requirement for anesthetics and/or muscle relaxants.

Intraoperative use of magnesium sulfate can also be associated with decreased incidences of nausea and vomiting after surgery, which could have been due to the lower consumption of anesthetics (i.e. volatile agents), rather than any antiemetic effect of magnesium sulfate. In addition, perioperative i.v. administration of magnesium sulfate has another advantageous effect, as it decreases the incidence of shivering by up to 70-90%. Previous studies investigating the analgesic efficacy of MgSO4 in general, gynaecological, ophthalmic and orthopaedic surgery have shown conflicting results, while reports regarding spine surgery are extremely limited.

Our study was designed to investigate the effects of MgSO4 on perioperative pain relief and postoperative quality of recovery after lumbar laminectomy surgery.


Description:

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Study Design


Intervention

Drug:
Magnesium Sulfate
Intravenous magnesium sulfate 20 mg/kg in 100ml isotonic saline 0.9% over a 15-min period before induction of anesthesia and 20 mg/kg/h by continuous i.v. infusion until surgery completion.
Isotonic saline 0.9%
Isotonic saline 0.9% 100ml over a 15-min period before induction of anesthesia and thereafter continuous i.v. infusion until surgery completion in dosage identical to magnesium sulfate group.

Locations

Country Name City State
Greece AHEPA University Hospital Thessaloniki

Sponsors (1)

Lead Sponsor Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Other Heart rate changes intraoperatively The changes in heart rate (beats per minute) intraoperatively after /during intravenous infusion of magnesium sulfate or isotonic saline 0.9% 180 minutes intraoperatively
Other Systemic blood pressure changes intraoperatively The changes in systemic blood pressure (mmHg) intraoperatively after /during intravenous infusion of magnesium sulfate or isotonic saline 0.9% 180 minutes intraoperatively
Other Postoperative adverse effects The incidence of shivering and nausea /vomiting after emergence from anesthesia after intravenous infusion of magnesium sulfate or isotonic saline 0.9% 24 hours after the emergence from anesthesia
Other Patients' satisfaction The patients' global satisfaction assessed the day after surgery using a 5-grade scale (1= worst and 5= totally satisfied) after intravenous infusion of magnesium sulfate or isotonic saline 0.9% 24 hours after surgery
Primary Analgesics consumption postoperatively in morphine equivalents The difference in analgesic consumption (assessed as mg of morphine equivalents) postoperatively after intravenous infusion of magnesium sulfate or isotonic saline 0.9% 24 hours after the emergence from anesthesia
Secondary Analgesics consumption intraoperatively The difference in analgesics consumption (µg of remifentanil) intraoperatively after /during intravenous infusion of magnesium sulfate or isotonic saline 0.9% 180 minutes intraoperatively
Secondary Pain intensity The difference in pain intensity postoperatively assessed by Visual Analogue Scale, Numerical Pain Scale or Verbal Pain Scale after intravenous infusion of magnesium sulfate or isotonic saline 0.9% 10 minutes after emergence from anesthesia, 2, 4 and 6 hours after the emergence from anesthesia
Secondary Time to first analgesic request in minutes The difference in the time frame (minutes) for analgesia request after emergence from anesthesia after intravenous infusion of magnesium sulfate or isotonic saline 0.9% 24 hours after the emergence from anesthesia
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