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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: mg sulphate

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Abassia
    • Cairo, Abassia, Egypt, 11591
      • Ain Shams University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): February 3, 2022
• Study Completion (ACTUAL): February 21, 2022

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (ACTUAL): February 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: oxygenation; mgso4; lung mechanics
• Other Study ID Numbers: FMASU R 07/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No