The Onset Time of Rocuronium in Emergency and Elective Surgery
Primary Purpose
Inguinal Hernia, Acute Appendicitis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Rocuronium elective surgery
Rocuronium emergency surgery
Propofol
Fentanyl
Ringer Lactate
Acceleromyography device
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring rocuronium, onset time, anxiety
Eligibility Criteria
Inclusion Criteria:
- BMI 18,5-24,9
- ASA 1
Exclusion Criteria:
- Allergy to used drugs during anesthesia
- Neuromuscular disease
- Liver and kidney failure
- Heart failure
- Anticipated difficult airway
- Using aminoglycosides
- BMI<18,5 and BMI>25
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Rocuronium elective surgery
Rocuronium emergency surgery
Arm Description
patients undergoing inguinal herniorrhaphy
patients undergoing appendectomy
Outcomes
Primary Outcome Measures
Train of Four Ratio (TOF 0.1)
anxiety score
Secondary Outcome Measures
Full Information
NCT ID
NCT02634255
First Posted
December 12, 2015
Last Updated
December 15, 2015
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02634255
Brief Title
The Onset Time of Rocuronium in Emergency and Elective Surgery
Official Title
The Prospective Randomized Comparison of the Onset Time of Rocuronium in Patients Undergoing Emergency and Elective Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Rocuronium, a nondepolarizing neuromuscular blocking agent, is used in general anesthesia to provide conditions for endotracheal intubating. Recommended dose is 0,6 mg/kg and 90 seconds after intravenous injection, patients can be intubated.
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
After obtaining ethics committee approval, American Society of Anesthesiologists physiological status 1 (ASA 1) patients, undergoing elective inguinal hernia repair and acute appendectomy, will be included to trial.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Acute Appendicitis
Keywords
rocuronium, onset time, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rocuronium elective surgery
Arm Type
Active Comparator
Arm Description
patients undergoing inguinal herniorrhaphy
Arm Title
Rocuronium emergency surgery
Arm Type
Experimental
Arm Description
patients undergoing appendectomy
Intervention Type
Drug
Intervention Name(s)
Rocuronium elective surgery
Other Intervention Name(s)
esmeron
Intervention Description
Rocuronium onset time in patients undergoing inguinal herniorrhaphy
Intervention Type
Drug
Intervention Name(s)
Rocuronium emergency surgery
Other Intervention Name(s)
esmeron
Intervention Description
Rocuronium onset time in patients undergoing appendectomy
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Type
Other
Intervention Name(s)
Ringer Lactate
Intervention Type
Device
Intervention Name(s)
Acceleromyography device
Other Intervention Name(s)
TOF Guard Sx
Primary Outcome Measure Information:
Title
Train of Four Ratio (TOF 0.1)
Time Frame
90 seconds after induction
Title
anxiety score
Time Frame
15 minutes before induction
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI 18,5-24,9
ASA 1
Exclusion Criteria:
Allergy to used drugs during anesthesia
Neuromuscular disease
Liver and kidney failure
Heart failure
Anticipated difficult airway
Using aminoglycosides
BMI<18,5 and BMI>25
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamze Gulgun, Md
Phone
+905308705073
Email
dr.gamzegulgun@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dilek Yazicioglu, Md
Phone
+905336957855
Email
dilek.yazicioglu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Sayın, Assoc Prof
Organizational Affiliation
Diskapi Yildirim Beyazit Education and Research Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17635389
Citation
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.
Results Reference
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PubMed Identifier
9322455
Citation
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.
Results Reference
background
PubMed Identifier
11465590
Citation
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.
Results Reference
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The Onset Time of Rocuronium in Emergency and Elective Surgery
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