drugset / Trial / NCT01570179

Sugammadex-dosing in Bariatric Patients

NCT01570179

Phase 3 Completed 34 enrolled Central Hospital, Nancy, France
RandomizedParallel-groupDouble-blindTreatment

Summary

Should the dose of sugammadex in morbid obese patients be calculated on the real body weight or the ideal body weight? The main objective of the trial is to compare in patients undergoing bariatric surgery the efficacy of sugammadex to obtain a TOF-ratio of 100% within 3 min when dosing is based on real body weight (control intervention) with dosing based on ideal body weight (experimental intervention). The research hypothesis is that both dosing regimens are equivalent The secondary objective of the trial is to compare the impact of the depth of neuromuscular blockade on the surgical conditions: deep block (TOF-count 1 - 3) will be compared with very deep block (TOF count = 0 and PTC \< 5)

Timeline

Start
2012-05
Primary completion
2012-07
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sugammadex Other / unclassified 2 mg/kg
Subject Sugammadex Other / unclassified 4 mg/kg

Indications

No indication recorded.