Sugammadex-dosing in Bariatric Patients (SugReBaCh-1)
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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 |
- 100% TOF-recovery 3 min after sugammadex [ Time Frame: 3 min ] [ Designated as safety issue: No ]
- 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 |
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 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 May 19, 2013