Sugammadex-dosing in Bariatric Patients

NCT01570179 | Completed Phase 3 DMC

• 1 other identifier: 2011-005504-14
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

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)

Conditions

Neuromuscular Blockade

Keywords

bariatric surgery; residual paralysis; surgical conditions

Outcome Measures

Primary Outcomes (1)

• 100% TOF-recovery 3 min after sugammadex

  3 min

Secondary Outcomes (1)

• impact of depth of block on surgical conditions

  every 15 min during surgery

Study Arms (4)

deep block ideal body weight

EXPERIMENTAL

Drug: ideal body weight based sugammadex reversal of deep block

deep block real body weight

ACTIVE COMPARATOR

Drug: real body weight based sugammadex reversal of deep block

moderate block ideal body weight

EXPERIMENTAL

Drug: ideal BW based sugammadex reversal of moderate block

moderate block real body weight

ACTIVE COMPARATOR

Drug: real body weight based sugammadex reversal of moderate block

Interventions

ideal BW based sugammadex reversal of moderate block DRUG

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

moderate block ideal body weight

real body weight based sugammadex reversal of moderate block DRUG

2 mg/kg sugammadex (based on real BW)

moderate block real body weight

real body weight based sugammadex reversal of deep block DRUG

4 mg/kg sugammadex (based on real BW)

deep block real body weight

ideal body weight based sugammadex reversal of deep block DRUG

4 mg/kg sugammadex (based on ideal BW)

deep block ideal body weight

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

CHU Strasbourg Hôpital Civil

Strasbourg, Alsace, 67091, France

Location

CHU Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 4, 2012
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

FR (2)