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NCT Number: NCT04769440

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

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

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Key information

Conditions

Anesthesia

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University Hospital

Cairo, Abassia, 11591, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mg sulphate

Drug

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

Primary outcomes

  1. Pao2

    Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion

    arterial oxygenation during surgery determined by Pao2

  2. Pao2/FIO2

    Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion

    arterial oxygenation during surgery determined by Pao2/FIO2

Secondary outcomes

  1. Static lung compliance

    Time frame: 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

    Time frame: One hour postoperatively

    serum mgso4 level

  3. dead space

    Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion

    dead space will be calculated as : Vd/Vt

  4. Dynamic lung compliance

    Time frame: 5 minutes after intubation to 90 minutes after starting drug infusion

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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