AminophyllineNCT06125665
Aminophylline on Perioperative Lung Mechanics in COPD Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery
A study testing Aminophylline-Dexmedetomidine and Dexmedetomidine in people with Aminophylline and Chronic Obstructive Pulmonary Disease, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Aminophylline, Chronic Obstructive Pulmonary Disease, Obese
- What is being tested?
- Aminophylline-Dexmedetomidine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Nov 2023to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Soliman R Naser, MD, 00201097929609, Soliman.naser@med.tanta.edu.eg
Osama M Rehab, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Aminophylline-Dexmedetomidine, Dexmedetomidine
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aminophylline-DexmedetomidineDrug
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.
DexmedetomidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 minutes after the beginning of the drug infusion.
Secondary outcomes (2)
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.
Measured: 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).
Measured: Up to 90 minutes after the beginning of the drug infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start11 Nov 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AminophyllineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soliman Ramadan Ahmed Naser, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125665
- Sponsor's protocol ID
- 36264PR361/9/23
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Aminophylline on Perioperative Lung Mechanics in COPD Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Prospective Randomized Double Blinded Trial
- ClinicalTrials.gov ID
- NCT06125665
- Acronym / sponsor ID
- 36264PR361/9/23
- Conditions
- Aminophylline, Chronic Obstructive Pulmonary Disease, Obese, Laparoscopic Bariatric Surgery, Dexmedetomidine, Lung Mechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aminophylline-Dexmedetomidine Group | Experimental | Drug: Aminophylline-Dexmedetomidine10 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. |
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine10 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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%).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aminophylline-Dexmedetomidine10 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 | Aminophylline-Dexmedetomidine Group |
| Dexmedetomidine10 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. | Drug | Dexmedetomidine |
Primary outcome
Static lung compliance
Time frame: Up to 90 minutes after the beginning of the drug infusion.
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.
2 secondary outcomes
Dynamic lung compliance
Time frame: Up to 90 minutes after the beginning of the drug infusion.
Intraoperative oxygenation
Time frame: Up to 90 minutes after the beginning of the drug infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aminophylline-Dexmedetomidine and Dexmedetomidine in people with Aminophylline and Chronic Obstructive Pulmonary Disease, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soliman R Naser, MD (00201097929609, Soliman.naser@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static lung compliance (time frame: Up to 90 minutes after the beginning of the drug infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.