Comparing the sedative effects of Dexmedetomidine and Propofol for eye surgery
Comparison of the Sedative Effects of Dexmedetomidine and Propofol During Peribulbar Anaesthesia in Patients Undergoing Vitrectomy Surgery: A Prospective Randomized Clinical Trial
This study is testing whether Dexmedetomidine or Propofol works better to keep patients comfortable and safe during eye surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Banī Suwayf, Beni Suef) |
| Trial ID | NCT06369103 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the sedative effects of Dexmedetomidine and Propofol during peribulbar anesthesia in patients undergoing vitrectomy surgery. It focuses on evaluating hemodynamic and respiratory parameters, recovery profiles, analgesic effects, cognitive function post-surgery, patient satisfaction, and any adverse events. The research is designed to identify which sedative agent provides better outcomes in terms of patient comfort and safety during this common outpatient ophthalmic procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20-70 years scheduled for vitrectomy surgery expected to last less than 2 hours.
Not a fit: Patients with cognitive impairments, severe cardiac or respiratory conditions, or those who refuse local anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient satisfaction and safety during vitrectomy surgeries by identifying the more effective sedative agent.
How similar studies have performed: Previous studies have explored the use of various sedatives in similar surgical settings, indicating potential benefits, but this specific comparison is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 20-70 years. * Expected time of surgery less than 2 hours Exclusion Criteria: * patients with an initial mini mental state examination (MMSE) score less than 23 * Patients refusing LA * Clotting abnormalities * Impaired mental status * Allergy to any of the study medications * Also, patients were excluded if they had severe cardiac disease, chronic obstructive lung disease, a history of sleep apnea and those who received general anesthesia.
Where this trial is running
Banī Suwayf, Beni Suef
- Beni Suef University Hospital — Banī Suwayf, Beni Suef, Egypt (Recruiting)
Study contacts
- Principal investigator: Dina M Fakhry, MD — Beni-Suef University
- Study coordinator: Dina M Fakhry, MD
- Email: dina_fakhry_91@yahoo.com
- Phone: +201289998680
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.