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Completed

NCT Number: NCT01570179

Sugammadex-dosing in Bariatric Patients

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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Key information

Conditions

Neuromuscular Blockade

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Strasbourg Hôpital Civil, Strasbourg, Alsace, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ideal BW based sugammadex reversal of moderate block

Drug

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

real body weight based sugammadex reversal of moderate block

Drug

2 mg/kg sugammadex (based on real BW)

real body weight based sugammadex reversal of deep block

Drug

4 mg/kg sugammadex (based on real BW)

ideal body weight based sugammadex reversal of deep block

Drug

4 mg/kg sugammadex (based on ideal BW)

Primary outcomes

  1. 100% TOF-recovery 3 min after sugammadex

    Time frame: 3 min

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: SugReBaCh-1

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 4, 2012
Registry last updated
Jan 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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