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

Phase 2

Completed

• Conditions: Anesthesia
• Interventions: Drug: mg sulphate

• Registration Number: NCT04769440
• Lead Sponsor: Ain Shams University

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

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 Timeline

• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-20
• Study First Posted: 2021-02-24
• Study Start: 2021-03-01
• Primary Completion: 2022-02-03
• Study Completion: 2022-02-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M group (Mg sulphate )	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

Primary Outcome Measures

Name	Time	Method
Pao2/FIO2	5 minutes after intubation to 90 minutes after starting drug infusion	arterial oxygenation during surgery determined by Pao2/FIO2
Pao2	5 minutes after intubation to 90 minutes after starting drug infusion	arterial oxygenation during surgery determined by Pao2

Secondary Outcome Measures

Name	Time	Method
mg sulphate level	One hour postoperatively	serum mgso4 level
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)
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)
dead space	5 minutes after intubation to 90 minutes after starting drug infusion	dead space will be calculated as : Vd/Vt

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, Abassia, Egypt