Abdominal CancerNCT03459417
Safety and Efficacy of Intrathecally Administered Magnesium Sulfate
A study testing intrathecal morphine+LA, intrathecal morphine+LA+ Mg sulp. 50 and intrathecal morphine+LA+ Mg sulp. 100 in people with Abdominal Cancer and Abdominal Pain, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
Magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. magnesium sulfate added to local anesthetics decrease postoperative opioid requirements. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Abdominal Cancer, Abdominal Pain
- What is being tested?
- intrathecal morphine+LA, intrathecal morphine+LA+ Mg sulp. 50 and intrathecal morphine+LA+ Mg sulp. 100
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with ASA physical status II or III, 21-year-old or older with major abdominal cancer surgery
Who cannot join
- significant coexisting, hepatorenal, or other end organ disease, obesity (BMI > 38 kg/m2), contraindication to regional anesthesia and sensitivity to local anesthetic drugs
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Asyut, 0020
About this study
Official title: Safety and Efficacy of Intrathecally Administered Magnesium Sulfate Added to Morphine and Local Anesthetics for Major Abdominal Cancer Surgery
Magnesium sulfate safety profile has been documented by histopathological analysis in experimental studies. magnesium sulfate added to local anesthetics decrease postoperative opioid requirements.
Read the 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
- Being tested
- intrathecal morphine+LA, intrathecal morphine+LA+ Mg sulp. 50, intrathecal morphine+LA+ Mg sulp. 100
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal morphine+LAProcedure or surgery
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. 50Procedure or surgery
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. 100Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| intrathecal morphine+LA | Active comparator | patients will receive intrathecal 15 mg (3 mL) of LA (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine. Receives: Procedure: intrathecal morphine+LA |
| intrathecal morphine+LA+Mg sulp. 50 | Active comparator | 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. Receives: Procedure: intrathecal morphine+LA+ Mg sulp. 50 |
| intrathecal morphine+LA+ Mg sulp.100 | Active comparator | 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. Receives: Procedure: intrathecal morphine+LA+ Mg sulp. 100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
change pain sensation using VAS scores
pain sensation using VAS scores with movement (0-10) 0=no pain 10=worst pain ever
Measured: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative
Secondary outcomes (1)
change in MAP
Mean arterial pressure
Measured: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start1 Jan 2018
- Primary completion1 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ali M. Elzohry, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459417
- Sponsor's protocol ID
- SECI-Assuit
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intrathecally Administered Magnesium Sulfate Added to Morphine and Local Anesthetics for Major Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03459417
- Acronym / sponsor ID
- SECI-Assuit
- Conditions
- Abdominal Cancer, Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intrathecal morphine+LA | Active comparator | Procedure: intrathecal morphine+LApatients 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 | Active comparator | Procedure: intrathecal morphine+LA+ Mg sulp. 50patients 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 | Active comparator | Procedure: intrathecal morphine+LA+ Mg sulp. 100patients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with ASA physical status II or III, 21-year-old or older with major abdominal cancer surgery
Key exclusion criteria (1 listed)
- significant coexisting, hepatorenal, or other end organ disease, obesity (BMI > 38 kg/m2), contraindication to regional anesthesia and sensitivity to local anesthetic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intrathecal morphine+LALumbar 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 or surgery | intrathecal morphine+LA |
| intrathecal morphine+LA+ Mg sulp. 50Lumbar 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 or surgery | intrathecal morphine+LA+Mg sulp. 50 |
| intrathecal morphine+LA+ Mg sulp. 100Lumbar 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. | Procedure or surgery | intrathecal morphine+LA+ Mg sulp.100 |
Primary outcome
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
1 secondary outcome
change in MAP
Time frame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrathecal morphine+LA, intrathecal morphine+LA+ Mg sulp. 50 and intrathecal morphine+LA+ Mg sulp. 100 in people with Abdominal Cancer and Abdominal Pain, run by South Egypt Cancer Institute at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change pain sensation using VAS scores (time frame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.