Sugammadex-dosing in Bariatric Patients

Study Overview
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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)

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

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* Drug: ideal BW based sugammadex reversal of moderate block
* Drug: real body weight based sugammadex reversal of moderate block
* Drug: real body weight based sugammadex reversal of deep block
* Drug: ideal body weight based sugammadex reversal of deep block


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deep block ideal body weight<br> | Drug: ideal body weight based sugammadex reversal of deep block<br>* 4 mg/kg sugammadex (based on ideal BW)<br>|
| Active Comparator: deep block real body weight<br> | Drug: real body weight based sugammadex reversal of deep block<br>* 4 mg/kg sugammadex (based on real BW)<br>|
| Experimental: moderate block ideal body weight<br> | Drug: ideal BW based sugammadex reversal of moderate block<br>* 2 mg/kg sugammadex (based og ideal body weight)<br>|
| Active Comparator: moderate block real body weight<br> | Drug: real body weight based sugammadex reversal of moderate block<br>* 2 mg/kg sugammadex (based on real BW)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100% TOF-recovery 3 min after sugammadex |  | 3 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of depth of block on surgical conditions | 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. | every 15 min during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, residual paralysis, surgical conditions