drugset / Trial / NCT03519633

Role of Curarization During Anesthesia for Laparoscopic Hysterectomy

NCT03519633

Phase 2 Completed 238 enrolled Campus-Bio-Medico University
RandomizedParallel-groupTriple-blindPrevention

Summary

The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic hysterectomy, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction.

Timeline

Start
2018-04-01
Primary completion
2024-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Neostigmine Other / unclassified
Subject Sugammadex Other / unclassified