Comparative Study of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade in Morbidly Obese Patients
NCT ID: NCT01629394
Last Updated: 2012-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2012-01-31
2012-11-30
Brief Summary
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Detailed Description
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By the end of the surgery, Group A and group E patients will receive sugammadex 2 mg/kg corrected body weight \[corrected body weight(CBW)=ideal body weight(IBW) + 40%(real body weight(RBW)-ideal body weight)\] when T2 arises in adductor pollicis. Group C and group G will receive neostigmine 50μg/kg corrected body weight when T2 arises in adductor pollicis. Group B and group F patients will receive sugammadex 2 mg/kg ideal body weight when T2 arises in adductor pollicis. Group D and group H patients will receive 50μg/kg neostigmine ideal body weight.
Investigators will proceed in continuous acceleromyography monitoring of adductor pollicis and corrugator supercilii during induction of anaesthesia, surgery, recovery and in the post anaesthesia care unit, recording TOF values. Total consumption of neuromuscular blocking agent, doses of reversal agents and clinical criteria of post operation residual curarization will also be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A: Sugammadex CBW-open
Group A patients will undergo open surgery and will receive sugammadex 2mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)\] when T2 arises in adductor pollicis.
Sugammadex
Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Group B: Sugammadex IBW-open
Group B patients will undergo open surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis.
Sugammadex
Single dose of sugammadex 2 mg/kg ( ideal body weight )
Group C: Neostigmine CBW-open
Group C patients will undergo open surgery and will receive neostigmine 50μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]when T2 arises in adductor pollicis.
Neostigmine
Single dose of neostigmine 50 μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Group D: Neostigmine-IBW
Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.
Neostigmine
Single dose of neostigmine 50 μg/kg ( ideal body weight )
Group E: Sugammadex CBW-Lap
Group E patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)\] when T2 arises in adductor pollicis.
Sugammadex
Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)\]
Group F: Sugammadex IBW-Lap
Group F patients will undergo laparoscopic surgery and will receive sugammadex 2mg/kg ( ideal body weight ) when T2 arises in adductor pollicis.
Sugammadex
Single dose of sugammadex 2 mg/kg ( ideal body weight )
Group G: Neostigmine CBW-Lap
Group C patients will undergo laparoscopic surgery and will receive neostigmine 50μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]when T2 arises in adductor pollicis.
Neostigmine
Single dose of neostigmine 50 μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Group H: Neostigmine IBW-Lap
Group D patients will undergo open surgery and will receive neostigmine 50μg/kg ( ideal body weight ) when T2 arises in adductor pollicis.
Neostigmine
Single dose of neostigmine 50μg/kg ( ideal body weight )
Interventions
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Sugammadex
Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Sugammadex
Single dose of sugammadex 2 mg/kg ( ideal body weight )
Neostigmine
Single dose of neostigmine 50 μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Neostigmine
Single dose of neostigmine 50 μg/kg ( ideal body weight )
Sugammadex
Single dose of 2 mg/kg corrected body weight \[corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)\]
Sugammadex
Single dose of sugammadex 2 mg/kg ( ideal body weight )
Neostigmine
Single dose of neostigmine 50 μg/kg corrected body weight \[corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)\]
Neostigmine
Single dose of neostigmine 50μg/kg ( ideal body weight )
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \< 60
* Patients written consent to participate in the study
Exclusion Criteria
* Patients refusal to participate in the study
* Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
* coexisting neuromuscular disease
* history of allergic reaction to neuromuscular blocking agents
* history of difficult intubation
* creatinine levels \> 159lmol/l
18 Years
60 Years
ALL
No
Sponsors
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University of Patras
OTHER
Responsible Party
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Prokopios Georgiou
Prokopios Georgiou M.D.
Principal Investigators
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Prokopios S. Georgiou, M.D.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Patras
Kriton S. Filos, Professor
Role: STUDY_CHAIR
University of Patras, Dept. of Anaesthesiology and Critical Care Medicine
Athena Siampalioti, M.D.
Role: STUDY_DIRECTOR
University Hospital of Patras
Locations
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University of Patras, Department of Anesthesiology and Critical Care Medicine
Pátrai, Achaia, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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952/21-3-12
Identifier Type: -
Identifier Source: org_study_id
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