Therapeutic Opioid Induced Constipation (Disorder)NCT03355807
Use of MgSO4 for Pain After Bariatric Surgery
A study testing Magnesium in people with Therapeutic Opioid Induced Constipation (Disorder), run by Yeditepe University Hospital.
Trial summary
The purpose of this study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapeutic Opioid Induced Constipation (Disorder)
- What is being tested?
- Magnesium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 15 Dec 2017
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 year old individuals who underwent laparoscopic sleeve gastrectomy.
Who cannot join
- One or more of the following: cardio - vascular and respiratory diseases, drug and/or alcohol abuse, use of daily an algesia 24 hours before the surgery, renal failure, and liver dysfunction.
About this study
Official title: Use of MgSO4 Reduced Opioid Consumption for Pain After Sleeve Gastrectomy Operations: A Prospective Randomized Clinical Trial
The purpose of this study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation
Read the detailed description
The purpose of this study is to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation.
Design: A prospective, randomized, controlled clinical study.
Setting: University hospital.
Participants: Eighty patients undergoing sleeve gastrectomy.
Measurements and Main Results: Visual analog scale for pain score, sedation score, mean arterial pressure, heart rate, and valid and invalid analgesic demand will record. Serum magnesium levels will determined at preoperative evaluation, postanesthesia care unit admission and at 24 hours. Side effects will also record.
- Being tested
- Magnesium
- Keywords
- sleeve gastrectomy, magnesium sulfate, postoperative pain, bariatric surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDrug
The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4
| Study group | Role | What they receive |
|---|---|---|
| Group MgSO4 | Experimental | The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4 (30 mg/kg by bolus and 10 mg/kg/h by infusion for 24 hours) Receives: Drug: Magnesium |
| Group Control | No intervention | the control group (group C, n _ 40) received the same amount of IV saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Item pain intensity measure assessed by using VAS scores
Pain was assessed by using VAS scores (0: no pain and 10: worst pain) imaginable recorded at 0, 1, 2, 4, 6, 24, and 24 hours.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Jan 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic Opioid Induced Constipation (Disorder)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients undergoing sleeve gastrectomy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nurcan kizilcik, Yeditepe University Hospital
- Investigators
- nurcan kizilcik, MD, Principal investigator, yeditepe universityiversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355807
- Sponsor's protocol ID
- obesity (magnesium)
- Status last verified
- May 2018
- First submitted
- 28 Sep 2017
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez A, Singh PM, Sinha AC. Postoperative analgesia in morbid obesity. Obes Surg. 2014 Apr;24(4):652-9. doi: 10.1007/s11695-014-1185-2.
PubMed 24431032
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of MgSO4 Reduced Opioid Consumption for Pain After Sleeve Gastrectomy Operations: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03355807
- Acronym / sponsor ID
- obesity (magnesium)
- Keywords
- sleeve gastrectomy, magnesium sulfate, postoperative pain, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 28 Nov 2017 (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.
The purpose of this study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation
Detailed description
The purpose of this study is to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation.
Design: A prospective, randomized, controlled clinical study.
Setting: University hospital.
Participants: Eighty patients undergoing sleeve gastrectomy.
Measurements and Main Results: Visual analog scale for pain score, sedation score, mean arterial pressure, heart rate, and valid and invalid analgesic demand will record. Serum magnesium levels will determined at preoperative evaluation, postanesthesia care unit admission and at 24 hours. Side effects will also record.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients undergoing sleeve gastrectomy.
| Arm | Type | Receives |
|---|---|---|
| Group MgSO4 | Experimental | Drug: MagnesiumThe magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4 (30 mg/kg by bolus and 10 mg/kg/h by infusion for 24 hours) |
| Group Control | No intervention | –the control group (group C, n _ 40) received the same amount of IV saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 65 year old individuals who underwent laparoscopic sleeve gastrectomy.
Key exclusion criteria (1 listed)
- One or more of the following: cardio - vascular and respiratory diseases, drug and/or alcohol abuse, use of daily an algesia 24 hours before the surgery, renal failure, and liver dysfunction.
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 |
|---|---|---|
| MagnesiumThe magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4 | Drug | Group MgSO4 |
Primary outcome
Item pain intensity measure assessed by using VAS scores
Time frame: 1 day
Pain was assessed by using VAS scores (0: no pain and 10: worst pain) imaginable recorded at 0, 1, 2, 4, 6, 24, and 24 hours.
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 22 May 2018.
- Results publication: PubMed 24431032Alvarez A, Singh PM, Sinha AC. Postoperative analgesia in morbid obesity. Obes Surg. 2014 Apr;24(4):652-9. doi: 10.1007/s11695-014-1185-2.
- bariatric surgery and anesthesiaLink provided by the sponsor.
- 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.
nurcan kizilcik, MD principal investigator
yeditepe universityiversity
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium in people with Therapeutic Opioid Induced Constipation (Disorder), run by Yeditepe University Hospital.
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 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Item pain intensity measure assessed by using VAS scores (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03355807, which also lists 1 linked publication.
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 22 May 2018.