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Sugammadex-dosing in Bariatric Patients

NCT01570179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-01-24

No results posted yet for this study

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)

Conditions

  • Neuromuscular Blockade

Interventions

DRUG

ideal BW based sugammadex reversal of moderate block

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

DRUG

real body weight based sugammadex reversal of moderate block

2 mg/kg sugammadex (based on real BW)

DRUG

real body weight based sugammadex reversal of deep block

4 mg/kg sugammadex (based on real BW)

DRUG

ideal body weight based sugammadex reversal of deep block

4 mg/kg sugammadex (based on ideal BW)

Sponsors & Collaborators

  • Central Hospital, Nancy, France

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01570179 on ClinicalTrials.gov