Sugammadex-dosing in Bariatric Patients

Neuromuscular Blockade Clinical Trial

— SugReBaCh-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570179
• Other study ID #: 2011-005504-14
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2012
• Last updated: January 23, 2013
• Start date: May 2012
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• ideal BW based sugammadex reversal of moderate block
2 mg/kg sugammadex (based og ideal body weight)
• real body weight based sugammadex reversal of moderate block
2 mg/kg sugammadex (based on real BW)
• real body weight based sugammadex reversal of deep block
4 mg/kg sugammadex (based on real BW)
• ideal body weight based sugammadex reversal of deep block
4 mg/kg sugammadex (based on ideal BW)

Locations

Country	Name	City	State
France	CHU Strasbourg Hôpital Civil	Strasbourg	Alsace
France	CHU Nancy	Vandoeuvre-Les-Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	100% TOF-recovery 3 min after sugammadex		3 min	No
Secondary	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	No