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The Effect of Doxapram Versus Theophylline on Diaphragmatic Function

Sponsor
Beni-Suef University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03894189
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. the effect of doxapram versus theophylline on diaphragmatic function [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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 .

    -

    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).

    1. Renal failure (creatinine >200 μm).

    2. History of seizure, or stroke.

    3. History of diaphragmatic palsy, cervical spine injury, or neuromuscular disease (eg, myasthenia gravis, Guillain-Barré syndrome).

    4. Lesion adjacent to the diaphragm

    5. Intra-abdominal hypertension (intra-abdominal pressure ≥12 mm Hg )

    6. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beni-Suef University Hospital Banī Suwayf Egypt

    Sponsors and Collaborators

    • Beni-Suef University

    Investigators

    • Principal Investigator: Samaa ak Rashwan, MD, Assisstant proffesor of anesthesia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Mar 28, 2019
    Last Update Posted:
    Mar 28, 2019
    Last Verified:
    Mar 1, 2019
    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:
    Theophylline
    Doxapram

    Study Results

    No Results Posted as of Mar 28, 2019