NCT03459417

Safety and Efficacy of Intrathecally Administered Magnesium Sulfate

Safety and Efficacy of Intrathecally Administered Magnesium Sulfate Added to Morphine and Local Anesthetics for Major Abdominal Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: South Egypt Cancer Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. magnesium sulfate added to local anesthetics decrease postoperative opioid requirements.

Detailed description

Spinal anesthesia is commonly used for the major abdominal cancer surgery because of decreasing the risks of general anesthesia.The quality and duration of sensory and motor block and decrease post operative pain is important in the major abdominal cancer surgery and patient's content satisfaction. Opioids in high doses and other drug such as clonidine and neostigmine added to local anesthetics to this purpose, but significant side effects. Magnesium sulfate block the N- methyle -D- aspartate (NMDA) channels in a voltage-dependent way to be improve the quality and duration of spinal block. However, the use of magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. Systemic delivery of magnesium sulfate decrease postoperative opioid requirements. In experimental studies, spinal injection of magnesium sulfate reduces the respond to painful stimulus in rats.

Conditions

• Abdominal Cancer
• Abdominal Pain

Interventions

Type	Name	Description
PROCEDURE	intrathecal morphine+LA	Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage. patients will receive intrathecal LA 15 mg (3 mL) (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine + magnesium sulfate 100 mg.
PROCEDURE	intrathecal morphine+LA+ Mg sulp. 50	Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage.patients will receive intrathecal 15 mg (3 mL) of hyperbaric bupivacaine 0.5% intrathecal +0.5 mg preservative free morphine + magnesium sulphate 50 mg.
PROCEDURE	intrathecal morphine+LA+ Mg sulp. 100	Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage.patients will receive intrathecal 15 mg (3 mL) of hyperbaric bupivacaine 0.5% intrathecal with 0.5 mg preservative free morphine + magnesium sulphate 100 mg.

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-05-01
• Completion: 2019-06-01
• First posted: 2018-03-08
• Last updated: 2019-12-13

Locations

1 site across 1 country: Egypt