Sugammadex-dosing in Bariatric Patients

Phase 3

Completed

• Conditions: Neuromuscular Blockade
• Interventions: Drug: real body weight based sugammadex reversal of moderate block; Drug: ideal body weight based sugammadex reversal of deep block; Drug: real body weight based sugammadex reversal of deep block; Drug: ideal BW based sugammadex reversal of moderate block

• Registration Number: NCT01570179
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-02
• Study First Posted: 2012-04-04
• Study Start: 2012-05
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moderate block real body weight	real body weight based sugammadex reversal of moderate block	-
deep block ideal body weight	ideal body weight based sugammadex reversal of deep block	-
deep block real body weight	real body weight based sugammadex reversal of deep block	-
moderate block ideal body weight	ideal BW based sugammadex reversal of moderate block	-

Primary Outcome Measures

Name	Time	Method
100% TOF-recovery 3 min after sugammadex	3 min

Secondary Outcome Measures

Name	Time	Method
impact of depth of block on surgical conditions	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.

Trial Locations

Locations (2)

CHU Strasbourg Hôpital Civil; 🇫🇷 Strasbourg, Alsace, France

CHU Nancy; 🇫🇷 Vandoeuvre-Les-Nancy, Lorraine, France