Comparing dexmedetomidine in topical versus peribulbar anesthesia for cataract surgery
Dexmedetomidine as an Additive to Topical Versus Peribulbar Anesthesia for Cataract Surgery
This study is testing whether adding dexmedetomidine to eye drops works better for pain relief during cataract surgery than using it with a shot around the eye.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University Academic / other |
| Locations | 1 site (Kafr Ash Shaykh, Kafrelsheikh) |
| Trial ID | NCT05692167 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of dexmedetomidine as an additive to topical anesthesia compared to its use in peribulbar anesthesia during cataract surgery. The research will involve patients classified as ASA physical status I or II who are scheduled for eye surgery. By assessing the outcomes of both anesthesia methods, the study seeks to determine which approach provides better pain management and patient comfort. The methodology includes administering dexmedetomidine in both topical and regional forms and measuring various efficacy parameters.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with ASA physical status classification I or II scheduled for cataract surgery.
Not a fit: Patients with contraindications to regional anesthesia, significant cardiovascular disease, or allergies to study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance pain management and patient comfort during cataract surgery.
How similar studies have performed: Previous studies have shown promising results with dexmedetomidine as an adjuvant in regional anesthesia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery Exclusion Criteria: * Patients who are younger than 18 years * The usual contraindications for regional anesthesia such as patients refusing LA * Clotting abnormalities * Impaired mental status * Allergy to any of the study medications * patients had the severe cardiac disease * chronic obstructive lung disease and a history of sleep apnea * contraindications to the use of dexmedetomidine * history or significant cardiovascular disease risk factors * significant coronary artery disease or any known genetic predisposition * history of any kind of drug allergy * drug abuse * psychological or other emotional problems * special diet or lifestyle * clinically significant abnormal findings in physical examination * electrocardiographic (ECG) or laboratory screening * known systemic disease requiring the use of anticoagulants.
Where this trial is running
Kafr Ash Shaykh, Kafrelsheikh
- Mohammed Fouad Mohamed Algyar — Kafr Ash Shaykh, Kafrelsheikh, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohammed F Algyar, MD — Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University
- Study coordinator: Mohammed F Algyar, MD
- Email: mohammad.algaiar@med.kfs.edu.eg
- Phone: 00201111645345
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.