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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Obese; Dexmedetomidine; Laparoscopic Bariatric Surgery; Lung Mechanics; Aminophylline
• Intervention / Treatment: Drug: Aminophylline-Dexmedetomidine; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soliman R Naser, MD; Phone Number: 00201097929609; Email: Soliman.naser@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Principal Investigator: Osama M Rehab, MD
      • Contact: Soliman R Naser, MD; Phone Number: 00201097929609; Email: Soliman.naser@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 20 to 60 years.
• Patients scheduled for laparoscopic bariatric surgery not exceeding three hours under general anesthesia.
• American Society of Anesthesiologists (ASA) class II to III.
• Patients who had no previous abdominal surgery.
• Patients with a body mass index (BMI) greater than 40 kg/m2and suffered obstructive lung disease diagnosed by pulmonary function tests (; forced vital capacity (FEV1\FVC) < 70%).
• Patients who are psychologically normal.

Exclusion Criteria:

• Patients who refuse to participate.
• Those with arrhythmia or receiving anti-arrhythmic medications.
• Those with significant coexisting diseases (e.g. kidney, heart, liver).
• Those with known allergy to any of allocated drugs.
• Those with excessive intraoperative blood loss more than allowable amount to every patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aminophylline-Dexmedetomidine Group; 10 minutes after endotracheal intubation, patients will receive 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: 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.
Active Comparator: Dexmedetomidine; 10 minutes after endotracheal intubation, patients will receive IV bolus of dexmedetomidine 0.5 microgm/kg 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static lung compliance	Static lung compliance will be calculated as: tidal volume/ [plateau pressure - Positive end-expiratory pressure (PEEP)] at 5 minutes after endotracheal intubation (baseline), 30 and 90 minutes after the beginning of the drug infusion.	Up to 90 minutes after the beginning of the drug infusion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic lung compliance	Dynamic lung compliance will be calculated as: tidal volume/ [peak airway pressure - Positive end-expiratory pressure (PEEP)] at 5 minutes after endotracheal intubation (baseline), 30 and 90 minutes after the beginning of the drug infusion.	Up to 90 minutes after the beginning of the drug infusion.
Intraoperative oxygenation	Intraoperative oxygenation will be measured at 5 minutes after endotracheal intubation (baseline), 30 and 90 minutes after the beginning of the drug infusion determined by (S/F ratio: SPO2/ FiO2).	Up to 90 minutes after the beginning of the drug infusion.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 11, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Purinergic Antagonists; Purinergic Agents; Protective Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Cardiotonic Agents; Hypnotics and Sedatives; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Dexmedetomidine; Aminophylline
• Other Study ID Numbers: 36264PR361/9/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No