Morbid ObesityNCT03729505
Impact of Pyloric Injection of Magnesium Sulfate and Lidocaine Mixture on Outcome After Sleeve Gastrectomy
A study testing Pyloric injection of magnesium sulfate and lidocaine mixture and Pyloric injection of saline in people with Morbid Obesity, run by Mansoura University at 1 site in Egypt.
Trial summary
Postoperative nausea and vomiting is a common adverse effect after sleeve gastrectomy, mostly due to increased intragastric pressure. The present trial aimed to assess the effect of pyloric injection of mixture of magnesium sulfate and lidocaine on postoperative gastric intraluminal pressure and incidence of nausea… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Pyloric injection of magnesium sulfate and lidocaine mixture and Pyloric injection of saline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 30 Aug 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that aged between18 and 65 years.
- American Society of Anesthesiologists (ASA) class I - III.
- Morbidly-obese patients who failed to achieve and maintain a clinically significant weight loss through supervised non-surgical methods for at least 6 months.
- Surgery was conducted as the first line of treatment in case of patients with BMI ≥ 50 kg/m2 (super obese).
Who cannot join
- Obesity secondary to endocrine disorders.
- History of any previous bariatric procedure.
- Impaired intellectual capacity or major psyciatric disorder.
- Sweet eaters who would not adopt a change of postoperative eating habits.
- Lack of willingness and motivation to embrace postoperative lifestyle changes.
- Substance abuse.
- Pregnancy or expected pregnancy in the following 12 to 18 months.
- Severe gastroesophageal reflux disease
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Impact of Pyloric Injection With Magnesium Sulphate and Lidocaine Mixture on Early Postoperative Outcome After Laparoscopic Sleeve Gastrectomy
Postoperative nausea and vomiting is a common adverse effect after sleeve gastrectomy, mostly due to increased intragastric pressure. The present trial aimed to assess the effect of pyloric injection of mixture of magnesium sulfate and lidocaine on postoperative gastric intraluminal pressure and incidence of nausea and vomiting.
- Conditions
- Morbid Obesity
- Being tested
- Pyloric injection of magnesium sulfate and lidocaine mixture, Pyloric injection of saline
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyloric injection of magnesium sulfate and lidocaine mixtureProcedure or surgery
100 mg / 2 ml of magnesium sulphate (Magnesium Sulfate®) is mixed with 5 ml of 2% lidocaine and injected in the pylorus
Pyloric injection of salineProcedure or surgery
5 ml of normal saline is injected in the pylorus
| Study group | Role | What they receive |
|---|---|---|
| Pyloric injection of magnesium sulfate and lidocaine mixture | Active comparator | After sleeve gastrectomy, the pylorus is injected with a mixture of magnesium sulfate and lidocaine Receives: Procedure: Pyloric injection of magnesium sulfate and lidocaine mixture |
| Pyloric injection of saline | Active comparator | After sleeve gastrectomy, the pylorus is injected with normal saline Receives: Procedure: Pyloric injection of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
incidence of postoperative nausea and vomiting as measured by special impact scale
Measured: first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start1 Jul 2017
- Primary completion30 Jul 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729505
- Sponsor's protocol ID
- mansoura66
- Status last verified
- Nov 2018
- First submitted
- 1 Nov 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pyloric Injection With Magnesium Sulphate and Lidocaine Mixture on Early Postoperative Outcome After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03729505
- Acronym / sponsor ID
- mansoura66
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 2 Nov 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.
Postoperative nausea and vomiting is a common adverse effect after sleeve gastrectomy, mostly due to increased intragastric pressure. The present trial aimed to assess the effect of pyloric injection of mixture of magnesium sulfate and lidocaine on postoperative gastric intraluminal pressure and incidence of nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyloric injection of magnesium sulfate and lidocaine mixture | Active comparator | Procedure: Pyloric injection of magnesium sulfate and lidocaine mixtureAfter sleeve gastrectomy, the pylorus is injected with a mixture of magnesium sulfate and lidocaine |
| Pyloric injection of saline | Active comparator | Procedure: Pyloric injection of salineAfter sleeve gastrectomy, the pylorus is injected with normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients that aged between18 and 65 years.
- American Society of Anesthesiologists (ASA) class I - III.
- Morbidly-obese patients who failed to achieve and maintain a clinically significant weight loss through supervised non-surgical methods for at least 6 months.
- Surgery was conducted as the first line of treatment in case of patients with BMI ≥ 50 kg/m2 (super obese).
Key exclusion criteria (8 listed)
- Obesity secondary to endocrine disorders.
- History of any previous bariatric procedure.
- Impaired intellectual capacity or major psyciatric disorder.
- Sweet eaters who would not adopt a change of postoperative eating habits.
- Lack of willingness and motivation to embrace postoperative lifestyle changes.
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 |
|---|---|---|
| Pyloric injection of magnesium sulfate and lidocaine mixture100 mg / 2 ml of magnesium sulphate (Magnesium Sulfate®) is mixed with 5 ml of 2% lidocaine and injected in the pylorus | Procedure or surgery | Pyloric injection of magnesium sulfate and lidocaine mixture |
| Pyloric injection of saline5 ml of normal saline is injected in the pylorus | Procedure or surgery | Pyloric injection of saline |
Primary outcome
Postoperative nausea and vomiting
Time frame: first 24 hours after surgery
incidence of postoperative nausea and vomiting as measured by special impact scale
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 2 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Sameh H Emile principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyloric injection of magnesium sulfate and lidocaine mixture and Pyloric injection of saline in people with Morbid Obesity, run by Mansoura University 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 4 inclusion and 8 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 2 Nov 2018. 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?
Postoperative nausea and vomiting (time frame: first 24 hours after surgery). 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 2 Nov 2018.