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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04769440
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
11.7
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: mg sulphate
 Phase 2

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

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of MgSo4 Infusion on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Surgery.A Randomized Clinical Trial
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Feb 3, 2022
Actual Study Completion Date :
Feb 21, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: M group (Mg sulphate )

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
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
Other Names:
  • mgso4

    		•
    No Intervention: C group (control )

    patients will receive 100 ml of normal saline intravenously over 30 minutes followed by saline infusion for 90 minutes

    Outcome Measures

    Primary Outcome Measures

    1. Pao2 [5 minutes after intubation to 90 minutes after starting drug infusion]

      arterial oxygenation during surgery determined by Pao2

    2. Pao2/FIO2 [5 minutes after intubation to 90 minutes after starting drug infusion]

      arterial oxygenation during surgery determined by Pao2/FIO2

    Secondary Outcome Measures

    1. Static lung compliance [5 minutes after intubation to 90 minutes after starting drug infusion]

      will be calculated as:tidal volume/(plateau pressure-positive end expiratory pressure)

    2. mg sulphate level [One hour postoperatively]

      serum mgso4 level

    3. dead space [5 minutes after intubation to 90 minutes after starting drug infusion]

      dead space will be calculated as : Vd/Vt

    4. Dynamic lung compliance [5 minutes after intubation to 90 minutes after starting drug infusion]

      will be calculated as :tidal volume/(peak airway pressure-positive end expiratory pressure)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Hospital Cairo Abassia Egypt 11591

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Marwa M Mowafi, MD, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marwa Mostafa Mohamed Ali Mowafi, Lecturer of anesthesia ,principal Investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT04769440
    Other Study ID Numbers:
    • FMASU R 07/2021
    First Posted:
    Feb 24, 2021
    Last Update Posted:
    Jul 20, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marwa Mostafa Mohamed Ali Mowafi, Lecturer of anesthesia ,principal Investigator, Ain Shams University
    mgso4
    oxygenation
    lung mechanics

    Study Results

    No Results Posted as of Jul 20, 2022