Comparing spinal anesthesia and saddle block for prostate surgery in elderly patients
Comparison of Hemodynamic Effect Between the Spinal Anesthesia and Saddle Block Using Levobupivacaine During Transurethral Resection of the Prostate in Cardiac Elderly Patients: A Randomized Clinical Trial
NA · New Valley University · NCT06014957
This study is testing whether spinal anesthesia or saddle block is safer for elderly patients with heart problems during prostate surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 65 Years to 80 Years |
| Sex | Male |
| Sponsor | New Valley University (other) |
| Locations | 1 site (New Cairo, Kharga) |
| Trial ID | NCT06014957 on ClinicalTrials.gov |
What this trial studies
This study evaluates the hemodynamic effects of spinal anesthesia versus saddle block using levobupivacaine during transurethral resection of the prostate (TURP) in elderly patients with cardiac issues. TURP is a common procedure for benign prostatic hyperplasia, particularly in patients with hypertension and compromised circulation. The study aims to determine which anesthesia method provides better stability in hemodynamic parameters, minimizing risks associated with general anesthesia. Participants will be monitored for their cardiovascular responses during the procedure.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 65 and older with ischemic heart disease and an ejection fraction between 35%-50%.
Not a fit: Patients under 65 years or those with conditions that increase intra-abdominal pressure or contraindications to spinal anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer anesthesia practices for elderly patients undergoing prostate surgery, reducing complications and improving outcomes.
How similar studies have performed: Other studies have shown promising results with regional anesthesia techniques in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) III, * with Ischemic Heart Disease (history of Myocardial Ischemia, * a history of a positive treadmill test result (Electro Cardio Graph stress test), * use of nitroglycerin, chronic stable angina for more than two months, or an ECG with abnormal Q waves), with ejection fraction (EF) 35%-50%, Exclusion Criteria: * patients under 65 years, * patients with any diseases that increase intraabdominal pressure (any intra-abdominal mass), * general contraindications of spinal anesthesia as patient refusal, coagulation disorders, local infection at the site of the block, psychiatric illness,
Where this trial is running
New Cairo, Kharga
- Ahmed Omar Twaisy — New Cairo, Kharga, Egypt (RECRUITING)
Study contacts
- Study coordinator: Ahmed Twaisy, MD
- Email: Twisy200235@med.nvu.edu.eg
- Phone: 01007410757
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.
Conditions: TURP Syndrome, Spinal Anesthesia