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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
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring rocuronium, onset time, anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 12, 2015
    Last Updated
    December 15, 2015
    Sponsor
    Diskapi Yildirim Beyazit Education and Research Hospital
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    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
    background
    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
    background

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    The Onset Time of Rocuronium in Emergency and Elective Surgery

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