Safety and Efficacy of Intrathecally Administered Magnesium Sulfate

South Egypt Cancer Institute

Status: Completed

Conditions: Abdominal Cancer; Abdominal Pain

Treatments: Procedure: intrathecal morphine+LA; Procedure: intrathecal morphine+LA+ Mg sulp. 100; Procedure: intrathecal morphine+LA+ Mg sulp. 50

Study type: Interventional

Funder types: Other

Identifiers

NCT03459417

SECI-Assuit

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with ASA physical status II or III, 21-year-old or older with major abdominal cancer surgery

Exclusion criteria

• significant coexisting, hepatorenal, or other end organ disease, obesity (BMI > 38 kg/m2), contraindication to regional anesthesia and sensitivity to local anesthetic drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups

intrathecal morphine+LA

Active Comparator group

Description:

patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine.

Treatment:

Procedure: intrathecal morphine+LA

intrathecal morphine+LA+Mg sulp. 50

Active Comparator group

Description:

patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine + magnesium sulfate 50 mg.

Treatment:

Procedure: intrathecal morphine+LA+ Mg sulp. 50

intrathecal morphine+LA+ Mg sulp.100

Active Comparator group

Description:

patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine + magnesium sulfate 100 mg.

Treatment:

Procedure: intrathecal morphine+LA+ Mg sulp. 100