NCT06125665

Aminophylline on Perioperative Lung Mechanics in COPD Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Impacts of Aminophylline on Perioperative Lung Mechanics in COPD Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Double Blinded Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the usefulness of adding aminophylline to dexmedetomidine intravenous infusion intraoperatively on oxygenation and lung mechanics in chronic obstructive pulmonary disease (COPD) morbidly obese patients undergoing bariatric surgery.

Detailed description

Bariatric surgery is considered the most effective treatment for patients suffering from morbid obesity, as it results in maintained loss of weight and clear impact on the comorbidities related to obesity. However, despite the advantages of anesthesia, it can have detrimental effects on the recovery of obese patients who have a high prevalence of respiratory conditions and sleep disorders. Obesity is usually related to other respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD). According to a meta-analysis encompassing more than 300,000 adult patients, obesity and asthma were interlinked, and as BMI increased, a higher risk of asthma was noticed. The use of dexmedetomidine infusion in morbid obese patients was assessed by many clinical trials. They revealed that the use of dexmedetomidine has the same analgesic effect as the use of fentanyl with greater hemodynamic stability obtained with the use of dexmedetomidine. Dexmedetomidine has the advantage of having no respiratory depressant effect. Also, it has an amnestic effect. Dexmedetomidine does not affect the sleep pattern and maintains the airway patency. Aminophylline is a compound of theophylline with ethylenediamine and most common uses in the airway obstruction such as asthma and COPD. primarily for its bronchodilating and central nervous stimulating effects. However, emprical evidence suggests that aminophylline, as an adenosine antagonist, can improve the recovery time from general anesthesia.

Conditions

• Aminophylline
• Chronic Obstructive Pulmonary Disease
• Obese
• Laparoscopic Bariatric Surgery
• Dexmedetomidine
• Lung Mechanics

Interventions

Type	Name	Description
DRUG	Aminophylline-Dexmedetomidine	10 minutes after endotracheal intubation, patients will receive intravenous (IV) bolus of dexmedetomidine 0.5 microgm/kg Lean body weight (LBW) over 15 min, followed immediately by intravenous infusion at 0.2 microgm /kg LBW/h and IV bolus of aminophylline of 5 mg/kg based on the ideal body weight (IBW) over 30 min, followed immediately by intravenous infusion at 0.6 mg/kg IBW/h. The study solutions will be diluted in 50 ml normal saline.
DRUG	Dexmedetomidine	10 minutes after endotracheal intubation, patients will receive intravenous (IV) bolus of dexmedetomidine 0.5 microgm/kg Lean body weight (LBW) over 15 min, followed immediately by intravenous infusion at 0.2 microgm /kg LBW/h. The study solutions will be diluted in 50 ml normal saline.

Timeline

• Start date: 2023-11-11
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2023-11-09
• Last updated: 2023-11-14

Locations

1 site across 1 country: Egypt