Comparing spinal anesthesia and general anesthesia for patients with sepsis
Comparative Study Between Continuous Spinal Anesthesia Versus General Anesthesia in Patients With Sepsis
This study tests whether using spinal anesthesia instead of general anesthesia can be safer and more effective for patients with sepsis during surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Elgharbia) |
| Trial ID | NCT05897151 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of continuous spinal anesthesia compared to general anesthesia in patients diagnosed with sepsis. It focuses on the challenges posed by hemodynamic instability in septic patients, who may experience increased risks of hypotension with conventional spinal anesthesia. By using a smaller dose of local anesthetic, the study aims to minimize hypotension while effectively managing anesthesia during surgical procedures. The trial will include patients who are hemodynamically stable and suitable for spinal anesthesia.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 years old with sepsis and a SOFA score of 7 or higher, who are hemodynamically stable and not on vasopressors.
Not a fit: Patients with known hypersensitivity to local anesthesia, septic shock, or severe spinal deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer anesthesia practices for high-risk septic patients, potentially improving surgical outcomes.
How similar studies have performed: While there is limited data on this specific comparison, similar studies have explored the use of spinal anesthesia in high-risk patients, indicating potential benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 21 years old * American Society of Anesthesiologists (III, IV) diagnosed with sepsis (Sequential Organ Failure Assessment (SOFA) score ≥ 7) * Hemodynamically stable and not on vasopressor due to lower limb pathology candidate for spinal anesthesia to drain source of infection. Exclusion Criteria: * Patients with known hypersensitivity to local anesthesia. * Infection at the site of injection. * Coagulopathy. * Septic shock. * Increase of intracranial pressure. * Severe deformity of the spinal column.
Where this trial is running
Tanta, Elgharbia
- Tanta University Hospitals — Tanta, Elgharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud R Ahmed, M.B.B.CH
- Email: mahmoud162104_pg@med.tanta.edu.eg
- Phone: +20 102 432 0926
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.