Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia for Elective Infra-Umbilical Surgeries
Launched by CAIRO UNIVERSITY · Jan 25, 2025
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how to give a local anesthetic called bupivacaine to children undergoing certain surgeries below the belly button, specifically to see if using a child's age instead of their weight for dosing is more effective. The researchers believe that age-based dosing may lead to better anesthesia while reducing the risk of side effects since children's bodies process medications differently as they grow. This is important because the traditional method of dosing based on weight might not always be the best approach, especially considering how children's bodies change as they age.
To participate in this trial, children between 1 and 6 years old who are scheduled for elective surgeries lasting up to 90 minutes may be eligible, as long as they are generally healthy (classified as ASA I or II). Some children may not qualify, including those with serious heart or neuromuscular issues, certain spinal conditions, or allergies to bupivacaine. If eligible, participants can expect to receive spinal anesthesia as part of their surgery, and their response to the medication will be monitored closely. This study is still in the planning stages and has not started recruiting participants yet.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • ASA I and II
- • Both genders
- • Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
- Exclusion Criteria:
- • Guardian refusal.
- • Children with major congenital heart disease, including septal defects.
- • Patients with neuromuscular disorders or high intracranial pressure.
- • Children with spinal deformities or morbid obesity (BMI above the 99th percentile).
- • Children with a history or family history of coagulation disorders.
- • Children with local infection at the site of skin puncture for spinal anesthesia.
- • Children with known allergy to bupivacaine.
- • Surgeries requiring head down (Trendelenburg) or prone position.
- • Unexpected prolongation of surgery \> 90 minutes.
About Cairo University
Cairo University, a premier institution in Egypt, is dedicated to advancing medical research and education through innovative clinical trials. With a strong emphasis on improving healthcare outcomes, the university collaborates with various stakeholders to conduct rigorous scientific studies that address critical health challenges. Leveraging its extensive resources and expert faculty, Cairo University aims to contribute valuable insights to the medical community and enhance patient care both locally and globally. Through its commitment to ethical research practices and excellence, the university plays a pivotal role in shaping the future of healthcare in the region.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Manal M Elgohary, M.D.
Study Chair
Cairo University
Hany M Elhady, M.D.
Study Director
Cairo University
Kareem MA Nawwar, M.D.
Study Director
Cairo University
Bassant A Heikal, M.B.B.Ch.
Principal Investigator
Cairo University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported