The Onset Time of Rocuronium in Emergency and Elective Surgery
NCT ID: NCT02634255
Last Updated: 2015-12-18
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
PHASE3
50 participants
INTERVENTIONAL
2015-12-31
2016-07-31
Brief Summary
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Anxiety levels may vary in patients undergoing emergency and elective surgery. Patients undergoing emergency surgery may display exaggerated laryngoscopic responses. The purpose of this study is to investigate the effect of patient anxiety levels on the onset time of rocuronium in terms of anxiety scores and train of four (TOF) 0.1 times.
Detailed Description
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Patients will be taken to the operating room without premedication. Spielberger's State-Trait Anxiety Inventory (STAI) will be administered to patients for determining anxiety level.
Electrocardiogram, blood pressure and peripheric oxygen saturation (SpO2) will be monitored. After opening intravenous access on hand dorsum, ringer lactate solution will be given. Neuromuscular monitoring and drug injections will be done as described in "Good Clinical Research Practice (GCRP) in pharmacodynamic studies of neuromuscular blocking agents".
TOF-Guard SX acceleromyograph (Organon-Teknika) will be monitored on corrugator supercilii muscle because of its sensitivity to laryngeal muscles. In induction of anesthesia, propofol 2 mg kg-1 and fentanyl 1 mcg kg-1 will be administered intravenously. After loss of conscious, TOF-Guard SX will be calibrated and then 0.6 mg kg-1 rocuronium will be administered in 5 seconds. 20 milliampere (mA) current TOF stimulation (200 ms, square wave, 2 Hz for 1.5 s) will be repeated in every 15 s. Patients will be intubated in TOF 0.1 time.
STAI score, heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, SpO2, TOF 0.1 time and intubation conditions will be compared between two groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rocuronium elective surgery
patients undergoing inguinal herniorrhaphy
Rocuronium elective surgery
Rocuronium onset time in patients undergoing inguinal herniorrhaphy
Propofol
Fentanyl
Ringer Lactate
Acceleromyography device
Rocuronium emergency surgery
patients undergoing appendectomy
Rocuronium emergency surgery
Rocuronium onset time in patients undergoing appendectomy
Propofol
Fentanyl
Ringer Lactate
Acceleromyography device
Interventions
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Rocuronium elective surgery
Rocuronium onset time in patients undergoing inguinal herniorrhaphy
Rocuronium emergency surgery
Rocuronium onset time in patients undergoing appendectomy
Propofol
Fentanyl
Ringer Lactate
Acceleromyography device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA 1
Exclusion Criteria
* Neuromuscular disease
* Liver and kidney failure
* Heart failure
* Anticipated difficult airway
* Using aminoglycosides
* BMI\<18,5 and BMI\>25
18 Years
65 Years
ALL
No
Sponsors
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Diskapi Yildirim Beyazit Education and Research Hospital
OTHER_GOV
Responsible Party
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Gamze GULGUN
Md
Principal Investigators
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Murat Sayın, Assoc Prof
Role: STUDY_CHAIR
Diskapi Yildirim Beyazit Education and Research Hospital
Central Contacts
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References
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Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.
Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.
Plaud B, Debaene B, Donati F. The corrugator supercilii, not the orbicularis oculi, reflects rocuronium neuromuscular blockade at the laryngeal adductor muscles. Anesthesiology. 2001 Jul;95(1):96-101. doi: 10.1097/00000542-200107000-00019.
Other Identifiers
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Rocuronium onset
Identifier Type: -
Identifier Source: org_study_id