Comparing Dexmedetomidine and Midazolam-Fentanyl for Sedation in Heart Surgery
Comparative Study Between Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation After Adult Valvular Cardiac Surgeries; a Prospective Randomized Blinded Clinical Trial
This study is testing whether a new sedative called dexmedetomidine can help patients have a smoother recovery after heart surgery compared to the usual sedatives, by reducing the time they need on a breathing machine and in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | Egymedicalpedia Industry-sponsored |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06464263 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of dexmedetomidine compared to midazolam-fentanyl for sedation and analgesia in patients undergoing elective valvular cardiac surgeries. The focus is on improving postoperative recovery by minimizing the duration of mechanical ventilation and associated complications. The study aims to identify an ideal sedative that provides comfort without significant side effects, allowing for rapid recovery and neurologic evaluation. By implementing fast-track extubation protocols, the study seeks to enhance patient outcomes and reduce ICU stay.
Who should consider this trial
Good fit: Ideal candidates for this study are adults scheduled for elective valvular cardiac surgeries.
Not a fit: Patients undergoing emergent valve cardiac surgeries or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced complications for patients undergoing cardiac surgery.
How similar studies have performed: Previous studies have shown promising results with dexmedetomidine in similar settings, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- This study will include patients undergoing elective adult valvular cardiac surgeries Exclusion Criteria: * Patient refusal. * Emergent valve cardiac surgeries. * Patients with known hypersensitivity to study drugs. * History of uncontrolled diabetes or hypertension. * Impaired kidney or liver functions. * Perioperative hemodynamic instability.
Where this trial is running
Cairo
- Al-Azhar University hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed husseiny Mahmoud, Lecturer — Cardio-Thoracic Surgery Department, Al-Azhar University
- Study coordinator: Ahmed Ramadan Ibrahim, MSC
- Email: 782014arar@gmail.com
- Phone: +201002749797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.