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

NCT06125665 | Unknown

• 1 other identifier: 36264PR361/9/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Dynamic lung compliance

  Up to 90 minutes after the beginning of the drug infusion.

• Intraoperative oxygenation

  Up to 90 minutes after the beginning of the drug infusion.

Study Arms (2)

Aminophylline-Dexmedetomidine Group

EXPERIMENTAL

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

Dexmedetomidine

ACTIVE COMPARATOR

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

Interventions

Aminophylline-Dexmedetomidine DRUG

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.

Aminophylline-Dexmedetomidine Group

Dexmedetomidine DRUG

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.

Dexmedetomidine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Soliman R Naser, MD

CONTACT

00201097929609; Soliman.naser@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 9, 2023
• Study Start: November 11, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)