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Safety and Efficacy of Intrathecally Administered Magnesium Sulfate

Primary Purpose

Abdominal Cancer, Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intrathecal morphine+LA
intrathecal morphine+LA+ Mg sulp. 50
intrathecal morphine+LA+ Mg sulp. 100
Sponsored by
South Egypt Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

intrathecal morphine+LA

intrathecal morphine+LA+Mg sulp. 50

intrathecal morphine+LA+ Mg sulp.100

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

change pain sensation using VAS scores
pain sensation using VAS scores with movement (0-10) 0=no pain 10=worst pain ever

Secondary Outcome Measures

change in MAP
Mean arterial pressure

Full Information

First Posted
February 21, 2018
Last Updated
December 11, 2019
Sponsor
South Egypt Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03459417
Brief Title
Safety and Efficacy of Intrathecally Administered Magnesium Sulfate
Official Title
Safety and Efficacy of Intrathecally Administered Magnesium Sulfate Added to Morphine and Local Anesthetics for Major Abdominal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer, Abdominal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intrathecal morphine+LA
Arm Type
Active Comparator
Arm Description
patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine.
Arm Title
intrathecal morphine+LA+Mg sulp. 50
Arm Type
Active Comparator
Arm 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.
Arm Title
intrathecal morphine+LA+ Mg sulp.100
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
intrathecal morphine+LA
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
intrathecal morphine+LA+ Mg sulp. 50
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
intrathecal morphine+LA+ Mg sulp. 100
Intervention Description
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 Outcome Measure Information:
Title
change pain sensation using VAS scores
Description
pain sensation using VAS scores with movement (0-10) 0=no pain 10=worst pain ever
Time Frame
at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative
Secondary Outcome Measure Information:
Title
change in MAP
Description
Mean arterial pressure
Time Frame
at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
City
Assiut
ZIP/Postal Code
0020
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of Intrathecally Administered Magnesium Sulfate

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