Safety and Efficacy of Intrathecally Administered Magnesium Sulfate

Not Applicable

Completed

• Conditions: Abdominal Pain; Abdominal Cancer
• Interventions: Procedure: intrathecal morphine+LA; Procedure: intrathecal morphine+LA+ Mg sulp. 50; Procedure: intrathecal morphine+LA+ Mg sulp. 100

• Registration Number: NCT03459417
• Lead Sponsor: South Egypt Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-02-21
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-08
• Primary Completion: 2019-05-01
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intrathecal morphine+LA	intrathecal morphine+LA	patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine.
intrathecal morphine+LA+Mg sulp. 50	intrathecal morphine+LA+ Mg sulp. 50	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.
intrathecal morphine+LA+ Mg sulp.100	intrathecal morphine+LA+ Mg sulp. 100	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.

Primary Outcome Measures

Name	Time	Method
change pain sensation using VAS scores	at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative	pain sensation using VAS scores with movement (0-10) 0=no pain 10=worst pain ever

Secondary Outcome Measures

Name	Time	Method
change in MAP	at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative	Mean arterial pressure

Trial Locations

Locations (1)

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt; 🇪🇬 Assiut, Egypt