The Effect of Doxapram Versus Theophylline on Diaphragmatic Function

NCT ID: NCT03894189

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Weaning Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Doxapram Hydrochloride

Intervention Type: DRUG

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

Theophylline

Intervention Type: DRUG

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

theophylline group (GROUP T)

the therapeutic loading dose (5mg/kg) followed by an infusion of (0.5 mg/kg/h)

Group Type: ACTIVE_COMPARATOR

Doxapram Hydrochloride

Intervention Type: DRUG

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

Theophylline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Doxapram

Eligibility Criteria

Inclusion Criteria

-

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.

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.

-

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Samaa Rashwan

Samaa Abou Alkassem Rashwan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samaa ak Rashwan, MD

Role: PRINCIPAL_INVESTIGATOR

Assisstant proffesor of anesthesia

Locations

Beni-Suef University Hospital

Banī Suwayf, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Samaa ak Rashwan, MD

Role: CONTACT

samakassemrashwan@gmail.com

020120159125

Facility Contacts

Samaa Rashwan, MD

Role: primary

0201270159125

Other Identifiers

Faculty Of Medicine,Beni -Suef

Identifier Type: -

Identifier Source: org_study_id