drugset / Trial / NCT01930747

Effect of Deep Neuromuscular Block (NMB), Inhalation or TIVA on Pneumoperitoneum.

NCT01930747

Phase 4 Completed 50 enrolled AZ Sint-Jan AV
RandomizedParallel-groupTriple-blindTreatment

Summary

The objective of this study is to compare the value of deep neuromuscular block (NMB) (using rocuronium) in laparoscopy versus high dose opioids (using remifentanil) or 1 minimum alveolar concentration (MAC) inhalation (using sevoflurane) for the surgeon. The study hypothesis is that laparoscopic workspace is larger when using rocuronium versus opioids or inhalation. Laparoscopic workspace is measured as the abdominal compliance and the pressure at volume zero (PV0) using the abdominal pressure volume relation. Three points allow to calculate the abdominal compliance and the pressure at zero volume (PV0).

Timeline

Start
2013-04
Primary completion
2015-12
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Remifentanil Small molecule 10 ug/kg Intravenous
Subject Remifentanil Small molecule 50 ug/kg Intravenous
Subject Rocuronium Other / unclassified 1 mg/kg Intravenous
Subject Sevoflurane Other / unclassified 1 unknown Inhaled

Indications

No indication recorded.