Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
128 participants
INTERVENTIONAL
2014-09-30
2016-06-30
Brief Summary
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The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard neuromuscular blockade
Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).
Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).
Deep neuromuscular blockade
Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Interventions
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Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).
Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.
Eligibility Criteria
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Inclusion Criteria
* Elective open upper abdominal surgery
* Can read and understand Danish
* Informed consent
Exclusion Criteria
* Severe renal disease, defined by S-creatinine\> 0.200 mmol/L, GFR \< 30ml/min or hemodialysis
* Neuromuscular disease that may interfere with neuromuscular data
* Abdominal mesh with size larger than 5\*5 cm
* Lactating or pregnant
18 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Matias Vested Madsen
MD, research assistant
Principal Investigators
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Matias V Madsen, MD
Role: PRINCIPAL_INVESTIGATOR
Herlev Hospital
Locations
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Aarhus University Hospital Nørrebrogade
Aarhus, , Denmark
Countries
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References
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Madsen MV, Scheppan S, Mork E, Kissmeyer P, Rosenberg J, Gatke MR. Influence of deep neuromuscular block on the surgeons assessment of surgical conditions during laparotomy: a randomized controlled double blinded trial with rocuronium and sugammadex. Br J Anaesth. 2017 Sep 1;119(3):435-442. doi: 10.1093/bja/aex241.
Madsen MV, Scheppan S, Kissmeyer P, Mork E, Rosenberg J, Gatke MR. Neuromuscular blockade for improvement of surgical conditions during laparotomy: protocol for a randomised study. Dan Med J. 2015 Oct;62(10):A5139.
Other Identifiers
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2014-001155-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Lap2014NMB
Identifier Type: -
Identifier Source: org_study_id
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