Effect of mgso4 on Oxygenation and Lung Mechanics in Morbidly Obese Patients During Bariatric Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of MgSo4 Infusion on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Surgery.A Randomized Clinical Trial

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: mg sulphate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M group (Mg sulphate )<br>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 | Drug: mg sulphate<br>* 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<br>* Other names: mgso4;|
| No Intervention: C group (control )<br>patients will receive 100 ml of normal saline intravenously over 30 minutes followed by saline infusion for 90 minutes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pao2 | arterial oxygenation during surgery determined by Pao2 | 5 minutes after intubation to 90 minutes after starting drug infusion | 
| Pao2/FIO2 | arterial oxygenation during surgery determined by Pao2/FIO2 | 5 minutes after intubation to 90 minutes after starting drug infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static lung compliance | will be calculated as:tidal volume/(plateau pressure-positive end expiratory pressure) | 5 minutes after intubation to 90 minutes after starting drug infusion | 
| mg sulphate level | serum mgso4 level | One hour postoperatively | 
| dead space | dead space will be calculated as : Vd/Vt | 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) | 5 minutes after intubation to 90 minutes after starting drug infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mgso4, oxygenation, lung mechanics