The Effect of Doxapram Versus Theophylline on Diaphragmatic Function

NCT03894189 | Unknown DMC

• 1 other identifier: Faculty Of Medicine,Beni -Suef
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Weaning Failure

Outcome Measures

Primary Outcomes (1)

• the effect of doxapram versus theophylline on diaphragmatic function

  : 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.

  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.

Study Arms (2)

doxapram group (GROUP D)

ACTIVE COMPARATOR

The patients in this group will receive loading dose of (1 mg/kg) followed by an infusion of (1mg/kg/h)

Drug: Doxapram Hydrochloride; Drug: Theophylline

theophylline group (GROUP T)

ACTIVE COMPARATOR

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

Drug: Doxapram Hydrochloride; Drug: Theophylline

Interventions

Doxapram Hydrochloride 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

Also known as: Doxapram

doxapram group (GROUP D); theophylline group (GROUP T)

Theophylline 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

doxapram group (GROUP D); theophylline group (GROUP T)

Eligibility Criteria

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

You may not qualify if:

• Age older than 60 years
• Preoperative left ventricular ejection fraction less than 30%
• Chronic obstructive pulmonary disease
• Significant hepatic disease (alanine aminotransferase or aspartate aminotransferase \>150 U/l).
• Renal failure (creatinine \>200 μm).
• History of seizure, or stroke.
• History of diaphragmatic palsy, cervical spine injury, or neuromuscular disease (eg, myasthenia gravis, Guillain-Barré syndrome).
• Lesion adjacent to the diaphragm
• Intra-abdominal hypertension (intra-abdominal pressure ≥12 mm Hg )
• Known allergy to the study drugs.
• Postoperative hemorrhage (chest tube drainage ≥ 200 ml/h).
• Surgical complications necessitating reoperation.
• Postoperative cardiac failure necessitating high-dose inotropes or intra -aortic balloon pump.
• Refractory hypoxemia (ratio of arterial oxygen tension \[PaO2\] to fraction of inspired oxygen \[FIO2\] \<150 mmHg).
• Occurrence of neurologic deficit.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Interventions

Doxapram; Theophylline

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Xanthines; Alkaloids; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Samaa ak Rashwan, MD

  Assisstant proffesor of anesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samaa ak Rashwan, MD

CONTACT

020120159125; samakassemrashwan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samaa Abou Alkassem Rashwan

Study Record Dates

• First Submitted: March 23, 2019
• First Posted: March 28, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

EG (1)