Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade
NCT ID: NCT01933425
Last Updated: 2015-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
14 participants
INTERVENTIONAL
2013-08-31
2014-04-30
Brief Summary
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Hypothesis:
Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Deep neuromuscular block followed by no neuromuscular block
Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.
Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
rocuronium
sugammadex
placebo
No neuromuscular block followed by deep neuromuscular block
No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.
Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
rocuronium
sugammadex
placebo
Interventions
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rocuronium
sugammadex
placebo
Eligibility Criteria
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Inclusion Criteria
* elective laparoscopic operation
* can read and understand Danish
* informed consent
Exclusion Criteria
* known allergy to medications that are included in the project,
* severe renal disease, defined by S-creatinine\> 0,200 mmol/L, GFR \< 30ml/min or hemodialysis),
* neuromuscular disease that may interfere with neuromuscular data,
* lactating or pregnant,
* impaired liver function,
* converting to laparotomy,
* perioperative use of neuromuscular blocking agents before randomization,
* pneumoperitoneum set to \>12 mmHg on the insufflator
18 Years
FEMALE
No
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Matias Vested Madsen
research assistent, MD
Principal Investigators
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Matias Vested Madsen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology Herlev Hospital
Olav Istre, MD, DMSc, professor
Role: STUDY_DIRECTOR
Department of minimal invasive gynecology, Aleris-Hamlet, Copenhagen
Locations
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Department of minimal invasive gynecology Aleris-Hamlet Private Hospital
Copenhagen, Søborg, Denmark
Countries
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Other Identifiers
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2013-001164-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NMBDK2013
Identifier Type: -
Identifier Source: org_study_id
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