drugset / Trial / NCT04791566

Preoperative High-dose Dexamethasone and Emergency Laparotomy

NCT04791566 ↗

Phase 4 Completed 120 enrolled Mirjana Cihoric
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this trial is to evaluate the effect of high-dose glucocorticoid on inflammatory response and recovery after emergency laparotomy in participants with intestinal obstruction and perforated viscus. Primary outcome is the reduction of C-reactive protein on postoperative day 1. Secondary outcomes are organ specific complications in the post anaesthesia phase, endothel and inflammatory markers, fluid status, preload dependency, pain, lung function, nausea and mobilization during the first 5 days after surgery, . The investigators hypothesize, that a preoperative single high dose of glucocorticoid reduces systemic inflammatory response after emergency laparotomy.

Timeline

Start
2021-03-01
Primary completion
2022-10-09
Completion
2022-12-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 1 mg/kg Intravenous