Sugammadex-dosing in Bariatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-07-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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deep block ideal body weight

Group Type EXPERIMENTAL

ideal body weight based sugammadex reversal of deep block

Intervention Type DRUG

4 mg/kg sugammadex (based on ideal BW)

deep block real body weight

Group Type ACTIVE_COMPARATOR

real body weight based sugammadex reversal of deep block

Intervention Type DRUG

4 mg/kg sugammadex (based on real BW)

moderate block ideal body weight

Group Type EXPERIMENTAL

ideal BW based sugammadex reversal of moderate block

Intervention Type DRUG

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

moderate block real body weight

Group Type ACTIVE_COMPARATOR

real body weight based sugammadex reversal of moderate block

Intervention Type DRUG

2 mg/kg sugammadex (based on real BW)

Interventions

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ideal BW based sugammadex reversal of moderate block

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

Intervention Type DRUG

real body weight based sugammadex reversal of moderate block

2 mg/kg sugammadex (based on real BW)

Intervention Type DRUG

real body weight based sugammadex reversal of deep block

4 mg/kg sugammadex (based on real BW)

Intervention Type DRUG

ideal body weight based sugammadex reversal of deep block

4 mg/kg sugammadex (based on ideal BW)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No