drugset / Trial / NCT04654429

Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients?

NCT04654429

Phase 4 Unknown 628 enrolled University of Malaya
RandomizedFactorialQuadruple-blindPrevention

Summary

This study will look at the incidence of post-spinal shivering (PSS) among the obstetrics population and will investigate whether higher operation theater (OT) temperature range or/and IV Ondansetron are able to reduce the incidence of PSS. This is a double-blind, randomized, factorial study, patients will be grouped into 4 groups - LP, HP, LO, HO (L= low-temperature range, H= high-temperature range, P= placebo, O=Ondansetron). All patients undergoing cesarean section under spinal anesthesia will be recruited, and it will be conducted in obstetrics OT.

Timeline

Start
2020-10-13
Primary completion
2022-12-30
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ondansetron Other / unclassified 4 mg Intravenous

Indications