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

NCT ID: NCT04769440

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-02-21

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

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

mg sulphate

Intervention Type: 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

C group (control )

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DRUG

Other Intervention Names

mgso4

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Mostafa Mohamed Ali Mowafi

Lecturer of anesthesia ,principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa M Mowafi, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Ain Shams University Hospital

Cairo, Abassia, Egypt

Countries

Egypt

Other Identifiers

FMASU R 07/2021

Identifier Type: -

Identifier Source: org_study_id