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Sugammadex-dosing in Bariatric Patients (SugReBaCh-1)

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ClinicalTrials.gov Identifier: NCT01570179
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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)


Condition or disease Intervention/treatment Phase
Neuromuscular Blockade 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 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing
Study Start Date : May 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: deep block ideal body weight Drug: ideal body weight based sugammadex reversal of deep block
4 mg/kg sugammadex (based on ideal BW)
Active Comparator: deep block real body weight Drug: real body weight based sugammadex reversal of deep block
4 mg/kg sugammadex (based on real BW)
Experimental: moderate block ideal body weight Drug: ideal BW based sugammadex reversal of moderate block
2 mg/kg sugammadex (based og ideal body weight)
Active Comparator: moderate block real body weight Drug: real body weight based sugammadex reversal of moderate block
2 mg/kg sugammadex (based on real BW)



Primary Outcome Measures :
  1. 100% TOF-recovery 3 min after sugammadex [ Time Frame: 3 min ]

Secondary Outcome Measures :
  1. impact of depth of block on surgical conditions [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570179


Locations
France
CHU Strasbourg Hôpital Civil
Strasbourg, Alsace, France, 67091
CHU Nancy
Vandoeuvre-Les-Nancy, Lorraine, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01570179     History of Changes
Other Study ID Numbers: 2011-005504-14
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Central Hospital, Nancy, France:
bariatric surgery
residual paralysis
surgical conditions