drugset / Trial / NCT03483350

Comp Granisetron Midazolam Comb in Lap Children

NCT03483350

Phase 3 Unknown 90 enrolled Assiut University
RandomizedParallel-groupOpen-labelPrevention

Summary

Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients. The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons.

Timeline

Start
2018-03
Primary completion
2018-08
Completion
2019-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Granisetron Other / unclassified 5 ug/kg Intravenous
Subject Granisetron Other / unclassified 10 ug/kg Intravenous
Subject Midazolam Small molecule 25 ug/kg Intravenous
Subject Midazolam Small molecule 50 ug/kg Intravenous

Indications

No indication recorded.