Using lipid emulsion to reverse spinal anesthesia for outpatient surgery
Lipid Emulsion for Reversal of Spinal Anesthesia in Ambulatory Surgery: A Randomized Controlled Trial
This study tests if a special fat solution can help people recover faster from spinal anesthesia after outpatient surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig, Al Sharqia) |
| Trial ID | NCT06988982 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intravenous lipid emulsion (ILE) in reversing the neural blockade caused by spinal anesthesia in patients undergoing ambulatory surgery. The goal is to address the limitations of spinal anesthesia, such as prolonged motor block and delayed recovery, which can hinder patient discharge. By comparing ILE to a placebo, the study aims to determine if ILE can facilitate quicker recovery and improve patient outcomes in outpatient settings. The research is particularly relevant as the demand for effective anesthetic techniques in ambulatory surgery continues to grow.
Who should consider this trial
Good fit: Ideal candidates are cooperative adults aged 21-70 with a BMI of 35 or less, undergoing elective ambulatory surgery under spinal anesthesia.
Not a fit: Patients with a history of allergy to local anesthetics, bleeding disorders, or cognitive dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce recovery times and improve discharge rates for patients undergoing outpatient surgeries.
How similar studies have performed: While the use of intravenous lipid emulsions has shown promise in treating local anesthetic toxicity, this specific application for reversing spinal anesthesia is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient acceptance. * Cooperative patient * Age 21-70 years old. * BMI ≤ 35 kg/m2 * ASA I - II. * Elective ambulatory surgery under spinal anesthesia (general surgery, urology, gynecology, orthopedic surgery). Exclusion Criteria: * History of allergy to the LA agents used in this study, * Skin lesion at needle insertion site, * Those with bleeding disorders, sepsis, liver disease and psychiatric disorders * History of cognitive dysfunction or mental illness
Where this trial is running
Zagazig, Al Sharqia
- Zagazig University Hospitals — Zagazig, Al Sharqia, Egypt (Recruiting)
Study contacts
- Principal investigator: Sherif M. S. Mowafy, MD — Anaesthesia, Intensive Care, and Pain Management Department. Faculty of Medicine, Zagazig University,
- Study coordinator: Sherif M. S. Mowafy, MD
- Email: sherifmowafy2012@gmail.com
- Phone: +201003523374
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.