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Search / Trial NCT06306040

Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric

Launched by ASSIUT UNIVERSITY · Mar 8, 2024

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two medications, nalbuphine and magnesium sulfate, to see if they can help prevent a condition called emergence agitation (EA) in young boys who are having surgery to repair hypospadias. Emergence agitation can make children confused or upset when they wake up from anesthesia. The trial will involve measuring how often EA occurs using a special scale designed for children. Researchers will also look at how long it takes for kids to wake up after surgery, any side effects they might experience, and their pain levels after the operation.

To participate in this study, boys aged 3 to 7 years old who weigh between 10 to 38 kg and are having elective hypospadias repair surgery under general anesthesia may be eligible. However, children with certain health issues, such as respiratory illnesses or neurological disorders, cannot take part. Families can expect regular check-ins during the study, and their satisfaction will also be measured. It’s important to note that this trial is not yet recruiting participants, so families will need to wait for it to start before they can consider enrolling their child.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • • Weight: 10 - 38 kg.
  • Age: 3-7 years.
  • ASA physical status: I-II.
  • Operation: elective hypospadias repair under general anesthesia
  • Exclusion Criteria:
  • • Parent's refusal.
  • Anticipated difficult airway.
  • Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia.
  • History of developmental delay or mental retardation or any neurological disease.
  • Known hypersensitivity to any drug used in this study.
  • Children with co-morbid conditions like congenital heart disease, respiratory pathology, central nervous system disorders or renal pathology

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Patients applied

0 patients applied

Trial Officials

Abualauon M Mohamed Abdelmohsen Rashwan, Lecturer

Study Director

Assiut University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported