drugset / Trial / NCT02622126

Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia

NCT02622126

Phase 2 Completed 60 enrolled Assiut University
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Maternal hypotension is the most frequent complication of a spinal Anesthesia. The prevention of spinal hypotension appears more likely to decrease the frequency and severity of associated adverse maternal symptoms than the treatment of established hypotension. Intravenous fluid administration prior to spinal anesthesia for caesarean section is accepted standard practice. The choice of fluid depends on individual and institutional habit, material cost (crystalloid is considerably cheaper) and the perceived relative benefits and risks. Uncommon but potentially serious adverse effect of colloids is impaired coagulation. Although pregnancy is associated with hypercoagulability, little is known about the effects of colloid preloading on coagulation in pregnant patients.

Timeline

Start
2016-01
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator hydroxyethyl starch Other / unclassified 500 ml
Comparator Atropine Other / unclassified 0.5 mg Intravenous
Comparator Bupivacaine Other / unclassified 10 mg Intrathecal
Comparator Bupivacaine Other / unclassified 12 mg Intrathecal
Comparator Ephedrine Small molecule 6 mg Intravenous
Comparator Morphine Other / unclassified 200 ug Intrathecal
Comparator sodium chloride Unknown 10 unknown