Clinical trial NCT04769440: Effect of mgso4 on Oxygenation and Lung Mechanics in Morbidly Obese Patients During Bariatric Surgery
Official title: Effect of MgSo4 Infusion on Oxygenation and Lung Mechanics in Morbidly Obese Patients Undergoing Bariatric Surgery.A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia
Keywords: mgso4
oxygenation
lung mechanics
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Pao2
timeFrame: 5 minutes after intubation to 90 minutes after starting drug infusion
measure: Pao2/FIO2
timeFrame: 5 minutes after intubation to 90 minutes after starting drug infusion
Secondary outcomes:
measure: Static lung compliance
timeFrame: 5 minutes after intubation to 90 minutes after starting drug infusion
measure: mg sulphate level
timeFrame: One hour postoperatively
measure: dead space
timeFrame: 5 minutes after intubation to 90 minutes after starting drug infusion
measure: Dynamic lung compliance
timeFrame: 5 minutes after intubation to 90 minutes after starting drug infusion
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
state: Abassia
Study officials:
affiliation: Ain Shams University
name: Marwa M Mowafi, MD
role: PRINCIPAL_INVESTIGATOR
References: