drugset / Trial / NCT02961842

Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery

NCT02961842 ↗

Completed 200 enrolled Mansoura University
RandomizedParallel-groupTriple-blindTreatment

Summary

The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.

Timeline

Start
2016-11-20
Primary completion
2017-03-09
Completion
2017-03-09

Outcome

Missed primary endpoint

paper the median of the difference (95% nonparametric confidence interval) was -2 (-5 to 0.00005) mg, P = .22. PMID 29461392 ↗

paper The combination of 500-mL colloid preload and 500-mL crystalloid coload did not reduce the total ephedrine dose PMID 29461392 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ringer acetate Other / unclassified 500 ml —
Subject Ringer acetate Other / unclassified 1000 ml —
Subject Volulyte Other / unclassified 500 ml —
Background Bupivacaine Other / unclassified 12.5 mg Intrathecal
Background Ephedrine Small molecule 3 mg Intravenous
Background Ephedrine Small molecule 5 mg Intravenous
Background Ephedrine Small molecule 10 mg Intravenous
Background Fentanyl Other / unclassified 15 ug Intrathecal

Indications

No indication recorded.