Comparing dexmedetomidine and fentanyl for spinal anesthesia in appendectomy
Fentanyl Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Spinal Anaesthesia for Appendectomy Patients; Peritoneal Symptomatic Effects: A Randomized Clinical Trial
This study is testing whether adding dexmedetomidine or fentanyl to spinal anesthesia can help people having an appendectomy feel better during surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 148 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Aswan University Academic / other |
| Locations | 1 site (Aswān, Aswan Governorate) |
| Trial ID | NCT06386783 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of dexmedetomidine and fentanyl as adjuvants to bupivacaine in spinal anesthesia for patients undergoing appendectomy. It focuses on reducing intraoperative peritoneal symptoms associated with the procedure. The study will involve patients aged 18 to 60 with ASA physical status class I and II, and will exclude those with certain medical conditions or complications. The research is particularly relevant in the context of the Covid-19 pandemic, as it explores safer anesthesia options that minimize aerosol generation.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 60 with ASA physical status class I and II undergoing appendectomy.
Not a fit: Patients with ASA grade III and IV, or those with complications such as active CNS disease or complicated appendicitis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of anesthesia in appendectomy patients, resulting in reduced intraoperative discomfort and faster recovery.
How similar studies have performed: Previous studies have shown promising results with similar approaches using adjuvants in spinal anesthesia, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. ASA physical status class I and II. 2. Age between 18 - 60 years of either sex. Exclusion Criteria: 1. ASA grade III and IV. 2. Infection at the site of injection. 3. Coagulopathy or anticoagulation. 4. Congenital anomalies of lower spine. 5. Active disease of CNS. 6. History of allergy to local anesthetics or the adjuvants. 7. Complicated appendicitis.
Where this trial is running
Aswān, Aswan Governorate
- Aswan University — Aswān, Aswan Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Ayman M Eldemrdash, MD — Aswan University
- Study coordinator: Soudy S Hammad, MD
- Email: soudi.salah@aswu.edu.eg
- Phone: +201014761523
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.