Sugammadex-dosing in Bariatric Patients (SugReBaCh-1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT01570179
First received: March 27, 2012
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sugammadex in Patients Undergoing Bariatric Surgery: An Equivalence Trial Comparing Real and Ideal Body Weight-based Dosing

Resource links provided by NLM:


Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • 100% TOF-recovery 3 min after sugammadex [ Time Frame: 3 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • impact of depth of block on surgical conditions [ Time Frame: every 15 min during surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: May 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT01570179     History of Changes
Other Study ID Numbers: 2011-005504-14
Study First Received: March 27, 2012
Last Updated: January 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on September 22, 2014