Sugammadex-dosing in Bariatric Patients (SugReBaCh-1)

Central Hospital, Nancy, France

Status and phase: Completed; Phase 3

Conditions: Neuromuscular Blockade

Treatments: Drug: real body weight based sugammadex reversal of deep block; Drug: ideal body weight based sugammadex reversal of deep block; Drug: ideal BW based sugammadex reversal of moderate block; Drug: real body weight based sugammadex reversal of moderate block

Study type: Interventional

Funder types: Other

Identifiers

NCT01570179

2011-005504-14

Details and patient eligibility

About

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)

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

adult patients undergoing bariatric surgery according to the respective criteria of the French Medical Authority (HAS) and having given their written informed consent after appropriate information

Exclusion criteria

not fulfilling the inclusion criteria, known or suspected allergy to any of the drugs used in that study, absence of written informed consent,doubt of pregnancy in women of childbearing age, pregnancy and breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 4 patient groups

deep block ideal body weight

Experimental group

Treatment:

Drug: ideal body weight based sugammadex reversal of deep block

deep block real body weight

Active Comparator group

Treatment:

Drug: real body weight based sugammadex reversal of deep block

moderate block ideal body weight

Experimental group

Treatment:

Drug: ideal BW based sugammadex reversal of moderate block

moderate block real body weight

Active Comparator group

Treatment:

Drug: real body weight based sugammadex reversal of moderate block