The Effect of Dexamethasone on Sugammadex Reversal
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine whether dexamethasone extends the duration of recovery from anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2014
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedAugust 13, 2015
August 1, 2015
11 months
May 12, 2014
August 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is the time to achieve TOF (Train of Four stimulation) ratio to 0.9 after sugammadex administration.
20 minutes
Study Arms (2)
Dexamethasone
EXPERIMENTALPatients are received dexamethasone via intravenous (iv) route of 0.5 mg.kg-1 (maximum dose of 8 mg) in group D at the induction of anesthesia.
Placebo
PLACEBO COMPARATORAn equal volume of saline iv in group S at the induction of anesthesia.
Interventions
Eligibility Criteria
You may qualify if:
- patients scheduled for elective tonsillectomy or adenoidectomy,
- aged 3-8 years
- with American Society of Anesthesiologists physical status 1 and 2
You may not qualify if:
- the presence of respiratory, hepatic, renal and cardiovascular disease,
- oropharyngeal or facial pathology
- neuromuscular disorder
- hypertension
- diabetes mellitus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cukurova University Faculty of Medicine
Adana, 01130, Turkey (Türkiye)
Related Publications (2)
Rezonja K, Sostaric M, Vidmar G, Mars T. Dexamethasone produces dose-dependent inhibition of sugammadex reversal in in vitro innervated primary human muscle cells. Anesth Analg. 2014 Apr;118(4):755-63. doi: 10.1213/ANE.0000000000000108.
PMID: 24651229RESULTPlaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa.
PMID: 19194156RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ersel Gulec, M.D.
Cukurova University Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist.Prof.
Study Record Dates
First Submitted
May 12, 2014
First Posted
May 13, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
August 13, 2015
Record last verified: 2015-08