drugset / Trial / NCT04720573

Reversal of Neuromuscular Blockade and Perioperative Arrhythmias

NCT04720573

RandomizedParallel-groupSingle-blindPrevention

Summary

Patients scheduled for elective abdominopelvic laparoscopic surgery under general anesthesia were included. Rocuronium was used for the neuromuscular blockade (NMB) and the level of NMB was monitored with train-of-four (TOF) measurements. The participants from whom informed consent had been received were allocated to two groups according to the agent used for reversal of NMB, sugammadex, or neostigmine. The ECG recordings of the subjects were followed with a rhythm Holter device throughout the procedure until the postoperative 12th hour. Additionally, preoperative and immediate postoperative 12-lead ECGs were evaluated for corrected QT calculations and QT dispersion. Proarrhythmogenicity was assessed with QT related measurements. The documented arrhythmic events on the Holter monitoring were designated as clinical end-points.

Timeline

Start
2019-06-01
Primary completion
2019-10-01
Completion
2019-11-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Neostigmine Other / unclassified 50 ug/kg
Comparator Sugammadex Other / unclassified 2 mg/kg

Indications

No indication recorded.