Skip to main content
OpenTrials
Completed

NCT Number: NCT03459417

Safety and Efficacy of Intrathecally Administered Magnesium Sulfate

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Cancer Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Asyut, 0020, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intrathecal morphine+LA

Procedure

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.

intrathecal morphine+LA+ Mg sulp. 50

Procedure

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.

intrathecal morphine+LA+ Mg sulp. 100

Procedure

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.

Primary outcomes

  1. change pain sensation using VAS scores

    Time frame: 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 outcomes

  1. change in MAP

    Time frame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative

    Mean arterial pressure

Sponsors and collaborators

Lead sponsor

South Egypt Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2018
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.