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The Effect of Doxapram Versus Theophylline on Diaphragmatic Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03894189
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Samaa Rashwan, Beni-Suef University

Brief Summary:

Doxapram is licensed for drug-induced post-anesthesia respiratory depression , arousal effect and return airway protective reflexes caused by barbiturates, volatile anesthetics, nitrous oxide or benzodiazepines over dosage.

Value of theophylline to stimulate the respiratory neuronal network has been examined by previous studies and increases the activity of respiratory muscles, including the intercostal , transversus abdominis muscles and the diaphragm, it also has bronchodilator and anti-inflammatory effects.


Condition or disease Intervention/treatment Phase
Weaning Failure Drug: Doxapram Hydrochloride Drug: Theophylline Not Applicable

Detailed Description:
This randomized comparative study will be conducted in the post-surgical cardio-thoracic intensive care unit in Beni -Suef University Hospital after approval of the department of anesthesiology, surgical ICU and pain management , and cardio thoracic department and the local ethics and research committee, and obtaining written informed consents from the patients to compare the effect of doxapram versus theophylline on diaphragmatic function using ultrasonography parameter: thickening fraction of the diaphragmatic muscle during respiration which defined as [(thickness at end-inspiration - thickness at end-expiration)/thickness at end-expiration] during spontaneous breathing trial as a primary outcome and its effect on weaning time and weaning success rate as secondary outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Doxapram Versus Theophylline on Diaphragmatic Function and Weaning From Mechanical Ventilation After Open Heart Surgery
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: doxapram group (GROUP D)
The patients in this group will receive loading dose of (1 mg/kg) followed by an infusion of (1mg/kg/h)
Drug: Doxapram Hydrochloride
the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug
Other Name: Doxapram

Drug: Theophylline
the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug

Active Comparator: theophylline group (GROUP T)
the therapeutic loading dose (5mg/kg) followed by an infusion of (0.5 mg/kg/h)
Drug: Doxapram Hydrochloride
the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug
Other Name: Doxapram

Drug: Theophylline
the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug




Primary Outcome Measures :
  1. the effect of doxapram versus theophylline on diaphragmatic function [ Time Frame: the study drugs will be infused for 1 hour,At the end of 60 min of SBT, the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. ]
    : thickening fraction of the diaphragmatic muscle during respiration which defined as [(thickness at end-inspiration - thickness at end-expiration)/thickness at end-expiration](18) (19) during spontaneous breathing trial as a primary outcome and its effect on weaning time and weaning success rate as secondary outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients (males and females) in the age group 20 -60 scheduled for elective open heart surgery ( e.g. coronary artery bypass grafting, valve replacement ) under cardiopulmonary bypass .

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Exclusion Criteria:The preoperative exclusion criteria:

  1. Age older than 60 years
  2. Preoperative left ventricular ejection fraction less than 30%
  3. Chronic obstructive pulmonary disease
  4. Significant hepatic disease (alanine aminotransferase or aspartate aminotransferase >150 U/l).
  5. Renal failure (creatinine >200 μm).
  6. History of seizure, or stroke.
  7. History of diaphragmatic palsy, cervical spine injury, or neuromuscular disease (eg, myasthenia gravis, Guillain-Barré syndrome).
  8. Lesion adjacent to the diaphragm
  9. Intra-abdominal hypertension (intra-abdominal pressure ≥12 mm Hg )
  10. Known allergy to the study drugs.

The Post enrollment exclusion criteria:

  1. Postoperative hemorrhage (chest tube drainage ≥ 200 ml/h).
  2. Surgical complications necessitating reoperation.
  3. Postoperative cardiac failure necessitating high-dose inotropes or intra -aortic balloon pump.
  4. Refractory hypoxemia (ratio of arterial oxygen tension [PaO2] to fraction of inspired oxygen [FIO2] <150 mmHg).
  5. Occurrence of neurologic deficit.
  6. -Myocardial ischemia (ST-segment depression) lasting more than 30 min
  7. Failure of spontaneous breathing trial.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894189


Contacts
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Contact: Samaa ak Rashwan, MD 020120159125 samakassemrashwan@gmail.com

Locations
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Egypt
Beni-Suef University Hospital Recruiting
Banī Suwayf, Egypt
Contact: Samaa Rashwan, MD    0201270159125      
Sponsors and Collaborators
Beni-Suef University
Investigators
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Principal Investigator: Samaa ak Rashwan, MD Assisstant proffesor of anesthesia
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Responsible Party: Samaa Rashwan, Samaa Abou Alkassem Rashwan, Beni-Suef University
ClinicalTrials.gov Identifier: NCT03894189    
Other Study ID Numbers: Faculty Of Medicine,Beni -Suef
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Theophylline
Doxapram
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Central Nervous System Stimulants