drugset / Trial / NCT02410590

Rocuronium + Sugammadex vs. Succinylcholine + Cisatracurium + Neostigmine/Atropine in Obese Participants (MK-8616-104)

NCT02410590

Phase 4 Withdrawn Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blind

Summary

The primary objective of this trial is to compare the preference between two strategies of neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium + Neostigmine/Atropine. This will be done evaluating the average verbal numerical scale (VNS) scores obtained from surgeons blinded to the drugs administered. The primary hypothesis is that the strategy "Rocuronium + Sugammadex" provides a better surgical visual field in obese participants undergoing laparoscopic abdominal surgery than the strategy "Succinylcholine + Cisatracurium + Neostigmine/Atropine" as measured by VNS scores.

Timeline

Start
2015-07
Primary completion
2016-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atropine Other / unclassified 0.01 mg/kg
Comparator Cisatracurium Small molecule
Comparator Neostigmine Other / unclassified 0.05 mg/kg
Subject Rocuronium Other / unclassified
Subject Sugammadex Other / unclassified 4 mg/kg Intravenous
Comparator Suxamethonium Other / unclassified 1 mg/kg

Indications

No indication recorded.