Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2013-01-31
2014-01-31
Brief Summary
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Detailed Description
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The following doses were chosen: 2.0 mg.kg-1, 2.2 mg.kg-1, 2.4 mg.kg-1, 2.6 mg.kg-1, 2.8 mg.kg-1.
The complete reversal of moderate rocuronium-induced neuromuscular blockade (NMB) considered a T4/T1 ratio ≥ 0.9 with the peripheral nerve stimulator and accelerometer (monitor of sequential electric stimuli) "train-of-four" (TOF).
After induction of general anesthesia and the calibration of the peripheral nerve stimulator and accelerometer, rocuronium 0.6 mg.kg-1 was injected.
Continuous intravenous infusion of the anesthetics propofol and remifentanil, and intermittent bolus of rocuronium were offered throughout the procedure.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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sugammadex ED90
Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).
The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.
sugammadex ED90
The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.
Interventions
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sugammadex ED90
The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* bariatric surgery
* informed consent signed
Exclusion Criteria
* use of drugs that could interfere with neuromuscular transmission,
* allergy to neuromuscular agents of the aminosteroids class,
* anticipated difficulty in airway management,
* renal failure
18 Years
60 Years
ALL
No
Sponsors
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Faculdade de Ciências Médicas da Santa Casa de São Paulo
OTHER
Responsible Party
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Mauro Prado da Silva
MD, Staff
Principal Investigators
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Lígia Andrade ST Mathias, MD, Ph.D
Role: STUDY_DIRECTOR
Full professor
References
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1983 metropolitan height and weight tables. Stat Bull Metrop Life Found. 1983 Jan-Jun;64(1):3-9. No abstract available.
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Blouin RA, Kolpek JH, Mann HJ. Influence of obesity on drug disposition. Clin Pharm. 1987 Sep;6(9):706-14.
de Boer HD, Driessen JJ, Marcus MA, Kerkkamp H, Heeringa M, Klimek M. Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: a multicenter, dose-finding and safety study. Anesthesiology. 2007 Aug;107(2):239-44. doi: 10.1097/01.anes.0000270722.95764.37.
Donati F. Sugammadex: a cyclodextrin to reverse neuromuscular blockade in anaesthesia. Expert Opin Pharmacother. 2008 Jun;9(8):1375-86. doi: 10.1517/14656566.9.8.1375.
Duffull SB, Dooley MJ, Green B, Poole SG, Kirkpatrick CM. A standard weight descriptor for dose adjustment in the obese patient. Clin Pharmacokinet. 2004;43(15):1167-78. doi: 10.2165/00003088-200443150-00007.
Epemolu O, Bom A, Hope F, Mason R. Reversal of neuromuscular blockade and simultaneous increase in plasma rocuronium concentration after the intravenous infusion of the novel reversal agent Org 25969. Anesthesiology. 2003 Sep;99(3):632-7; discussion 6A. doi: 10.1097/00000542-200309000-00018.
Janmahasatian S, Duffull SB, Ash S, Ward LC, Byrne NM, Green B. Quantification of lean bodyweight. Clin Pharmacokinet. 2005;44(10):1051-65. doi: 10.2165/00003088-200544100-00004.
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Demirkaya M, Kelsaka E, Sarihasan B, Bek Y, Ustun E. The optimal dose of remifentanil for acceptable intubating conditions during propofol induction without neuromuscular blockade. J Clin Anesth. 2012 Aug;24(5):392-7. doi: 10.1016/j.jclinane.2011.11.006.
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Gupta PK, Hopkins PM. Effect of concentration of local anaesthetic solution on the ED(5)(0) of bupivacaine for supraclavicular brachial plexus block. Br J Anaesth. 2013 Aug;111(2):293-6. doi: 10.1093/bja/aet033. Epub 2013 Mar 26.
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Other Identifiers
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191.837
Identifier Type: -
Identifier Source: org_study_id
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