AnesthesiaPhase 2NCT04769440
Effect of mgso4 on Oxygenation and Lung Mechanics in Morbidly Obese Patients During Bariatric Surgery
A Phase 2 study testing mg sulphate in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- mg sulphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 21 Feb 2022
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients age between 21-60 years.
- BMI more than 40kg/m2
- Patients with restrictive lung disease(FVC>70%)
- American society of Anesthesiologists(ASA) physical status II
- No previous abdominal surgery
- Scheduled for laparoscopic bariatric surgery not exceeding 3 hours.
Who cannot join
- Patient refusal to participate in the study
- ASA physical status more than II
- patients with heart failure
- Kidney disease
- Patients on antiarrhythmic drugs
- Patients taking beta or calcium channel blockers
- Allergy to study drugs
- Patients with combined restrictive-obstructive lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of MgSo4 Infusion on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Surgery.A Randomized Clinical Trial
The purpose of this trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery
Read the detailed description
Background and objectives: morbidly obese patients are characterized by a high prevalence of restrictive lung disease. Respiratory mechanics are significantly altered in obesity. These changes are exacerbated with general anesthesia .Obesity also results in reduced lung and chest wall compliance ,increased lung resistance ,reduced oxygenation.MgSo4 is promising in managing several respiratory disorders.it cause smooth muscle relaxation and reduce airflow obstruction.
The objective of this trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery.
the following will be recorded :intraoperative oxygenation,lung mechanics,MAP,HR,EtCO2,plateau and peak airway pressure,sedation score,serum mgso4 level,change in P/F ratio and dynamic lung compliance,respiratory rate postoperative
- Conditions
- Anesthesia
- Being tested
- mg sulphate
- Keywords
- mgso4, oxygenation, lung mechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mg sulphateDrug
Also called mgso4
mgso4 infusion will start 15 minutes after intubation , 30 mg/kg LBW of 10%mgso4 in 100 ml normal saline I.V ,over 30 minutes followed by 10 mg/kg LBW for 90 minutes
| Study group | Role | What they receive |
|---|---|---|
| M group (Mg sulphate ) | Active comparator | patients will receive 30mg/kg LBW of 10%mgso4 in 100 ml normal saline intravenously over 30 minutes as a loading dose ,followed by 10 mg /kg LBW for 90 minutes Receives: Drug: mg sulphate |
| C group (control ) | No intervention | patients will receive 100 ml of normal saline intravenously over 30 minutes followed by saline infusion for 90 minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pao2
arterial oxygenation during surgery determined by Pao2
Measured: 5 minutes after intubation to 90 minutes after starting drug infusion
Pao2/FIO2
arterial oxygenation during surgery determined by Pao2/FIO2
Measured: 5 minutes after intubation to 90 minutes after starting drug infusion
Secondary outcomes (4)
Static lung compliance
will be calculated as:tidal volume/(plateau pressure-positive end expiratory pressure)
Measured: 5 minutes after intubation to 90 minutes after starting drug infusion
mg sulphate level
serum mgso4 level
Measured: One hour postoperatively
dead space
dead space will be calculated as : Vd/Vt
Measured: 5 minutes after intubation to 90 minutes after starting drug infusion
Dynamic lung compliance
will be calculated as :tidal volume/(peak airway pressure-positive end expiratory pressure)
Measured: 5 minutes after intubation to 90 minutes after starting drug infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Mar 2021
- Primary completion3 Feb 2022
- Study completion21 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mostafa Mohamed Ali Mowafi, Ain Shams University
- Investigators
- Marwa M Mowafi, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769440
- Sponsor's protocol ID
- FMASU R 07/2021
- Status last verified
- Jul 2022
- First submitted
- 14 Feb 2021
- Last updated
- 20 Jul 2022
- Results posted
- 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of MgSo4 Infusion on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Surgery.A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04769440
- Acronym / sponsor ID
- FMASU R 07/2021
- Conditions
- Anesthesia
- Keywords
- mgso4, oxygenation, lung mechanics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 21 Feb 2022 (actual)
- First posted
- 24 Feb 2021 (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 trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery
Detailed description
Background and objectives: morbidly obese patients are characterized by a high prevalence of restrictive lung disease. Respiratory mechanics are significantly altered in obesity. These changes are exacerbated with general anesthesia .Obesity also results in reduced lung and chest wall compliance ,increased lung resistance ,reduced oxygenation.MgSo4 is promising in managing several respiratory disorders.it cause smooth muscle relaxation and reduce airflow obstruction.
The objective of this trial is to study the effect of mgso4 infusion on oxygenation and lung mechanics in morbidly obese patients undergoing bariatric surgery.
the following will be recorded :intraoperative oxygenation,lung mechanics,MAP,HR,EtCO2,plateau and peak airway pressure,sedation score,serum mgso4 level,change in P/F ratio and dynamic lung compliance,respiratory rate postoperative
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M group (Mg sulphate ) | Active comparator | Drug: mg sulphatepatients will receive 30mg/kg LBW of 10%mgso4 in 100 ml normal saline intravenously over 30 minutes as a loading dose ,followed by 10 mg /kg LBW for 90 minutes |
| C group (control ) | No intervention | –patients will receive 100 ml of normal saline intravenously over 30 minutes followed by saline infusion for 90 minutes |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients age between 21-60 years.
- BMI more than 40kg/m2
- Patients with restrictive lung disease(FVC>70%)
- American society of Anesthesiologists(ASA) physical status II
- No previous abdominal surgery
Key exclusion criteria (8 listed)
- Patient refusal to participate in the study
- ASA physical status more than II
- patients with heart failure
- Kidney disease
- Patients on antiarrhythmic 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 |
|---|---|---|
| mg sulphateAlso: mgso4mgso4 infusion will start 15 minutes after intubation , 30 mg/kg LBW of 10%mgso4 in 100 ml normal saline I.V ,over 30 minutes followed by 10 mg/kg LBW for 90 minutes | Drug | M group (Mg sulphate ) |
Primary outcome
Pao2
Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion
arterial oxygenation during surgery determined by Pao2
Pao2/FIO2
Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion
arterial oxygenation during surgery determined by Pao2/FIO2
4 secondary outcomes
Static lung compliance
Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion
mg sulphate level
Time frame: One hour postoperatively
dead space
Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion
Dynamic lung compliance
Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion
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 20 Jul 2022.
- 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.
Marwa M Mowafi, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mg sulphate in people with Anesthesia, run by Ain Shams 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 6 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 20 Jul 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pao2 (time frame: 5 minutes after intubation to 90 minutes after starting drug infusion). The study lists 2 primary outcomes in all. 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 20 Jul 2022.