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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COMPLETED
NA
44 participants
INTERVENTIONAL
2015-05-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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dexamethasone
Dexamethasone is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
Dexamethasone
active comparator
sugammadex
sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery
normal saline
Normal saline is administered intravenously before induction of anaesthesia. Deep neuromuscular blockade is induced with rocuronium and is assessed by acceleromyography (post-tetanic count stimulation) on the ulnar nerve of the patient's hand. At the end of surgery, sugammadex 4 mg/kg is administered to reverse neuromuscular blockade.
Normal Saline
placebo controlled intervention
sugammadex
sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery
Interventions
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Dexamethasone
active comparator
Normal Saline
placebo controlled intervention
sugammadex
sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* laparoscopic cholecystectomy
* operation \< 3 hours
Exclusion Criteria
* ASA physical status \>3
* central nervous system diseases
* severe psychiatric disorders under treatment
* cognitive dysfunction
* known or suspected allergy to the administered drugs
* operations \> 3 hours
* surgical intraoperative complications-open cholecystectomy
* severe renal or liver disease
* diabetes melitus
* immunosuppressed patients
* chronic immunosuppresant therapy (corticosteroids or other drugs)
* all contraindications to corticosteroids administration
* patiens on chronic use of opioids
18 Years
70 Years
ALL
Yes
Sponsors
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Attikon Hospital
OTHER
Responsible Party
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Chrysanthi Batistaki
Assistant Professor of Anesthesiology, 2nd Department of Anesthesiology, School of Medicine, University of Athens, Greece
Locations
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2nd Department of Anesthesiology, Attikon Hospital, 1 Rimini str.
Athens, , Greece
Countries
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Other Identifiers
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711/19-3-15
Identifier Type: -
Identifier Source: org_study_id
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