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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769440
• Other study ID #: FMASU R 07/2021
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: February 21, 2022

Study information

• Verified date: July 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 21, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo	Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pao2	arterial oxygenation during surgery determined by Pao2	5 minutes after intubation to 90 minutes after starting drug infusion
Primary	Pao2/FIO2	arterial oxygenation during surgery determined by Pao2/FIO2	5 minutes after intubation to 90 minutes after starting drug infusion
Secondary	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
Secondary	mg sulphate level	serum mgso4 level	One hour postoperatively
Secondary	dead space	dead space will be calculated as : Vd/Vt	5 minutes after intubation to 90 minutes after starting drug infusion
Secondary	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