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

NCT04769440 | Completed Phase 2

• 1 other identifier: FMASU R 07/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Anesthesia

Keywords

mgso4; oxygenation; lung mechanics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Static lung compliance

  5 minutes after intubation to 90 minutes after starting drug infusion

• mg sulphate level

  One hour postoperatively

• dead space

  5 minutes after intubation to 90 minutes after starting drug infusion

• Dynamic lung compliance

  5 minutes after intubation to 90 minutes after starting drug infusion

Study Arms (2)

M group (Mg sulphate )

ACTIVE COMPARATOR

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

C group (control )

NO INTERVENTION

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

Interventions

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

Also known as: mgso4

M group (Mg sulphate )

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Abassia, 11591, Egypt

Location

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Marwa M Mowafi, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia ,principal Investigator

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 24, 2021
• Study Start: March 1, 2021
• Primary Completion: February 3, 2022
• Study Completion: February 21, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)