Sugammadex-dosing in Bariatric Patients

Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01570179

Acronym

SugReBaCh-1

Enrollment

Registered

2012-04-04

Start date

2012-05-31

Completion date

2012-07-31

Last updated

2013-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

bariatric surgery, residual paralysis, surgical conditions

Brief 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)

Interventions

DRUGideal BW based sugammadex reversal of moderate block

2 mg/kg sugammadex (based og ideal body weight)

DRUGreal body weight based sugammadex reversal of moderate block

2 mg/kg sugammadex (based on real BW)

DRUGreal body weight based sugammadex reversal of deep block

4 mg/kg sugammadex (based on real BW)

DRUGideal body weight based sugammadex reversal of deep block

4 mg/kg sugammadex (based on ideal BW)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
100% TOF-recovery 3 min after sugammadex	3 min

Secondary

Measure	Time frame	Description
impact of depth of block on surgical conditions	every 15 min during surgery	to evaluate the impact of neuromuscular blockade on surgical conditions, the The King Score (King M, Anesthesiology 2000; 93:1392 - 7) will be applied every 15 min throught surgery by the surgeon (blinded to the study protocol)King-Score: from 1 to 4 with 1 excellent conditions, 2 good conditions, 3 acceptable conditions and 4 poor conditions.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026