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Comparison of Methods to Facilitate Rapid Sequence Intubation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01479751
Recruitment Status : Completed
First Posted : November 24, 2011
Last Update Posted : August 27, 2012
Sponsor:
Information provided by (Responsible Party):
Kim Mihyun, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE November 22, 2011
First Posted Date  ICMJE November 24, 2011
Last Update Posted Date August 27, 2012
Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
Intubation score [ Time Frame: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection. ]
Patients are tracheally intubated, and intubation scores(poor, good,excellent)are rated.
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
Roc onset [ Time Frame: participants will be followed when TOF % reaches 0%, within an expected average of 4 min from injection of Roc. ]
Time from injection of Roc until TOF % reaches 0% using TOF-Watch sx.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • Roc duration [ Time Frame: participants will be followed when TOF count reaches two, an expected average of 40 min. ]
    Time from the start of rocuronium injection until reappearance of two muscle twitches in TOF stimulations is measured, using ToF-Watch sx.
  • Roc onset [ Time Frame: participants will be followed when TOFcount =0 within an expected average of 4 min from the start of rocuronium injection. ]
    Time from the start of rocuronium injection until TOF count=0 using TOF-Watch sx.
  • Hemodynamic variables [ Time Frame: participants will be followed at baseline, before and for 5 min after the intubation, an expected average of 8 min after the start of anesthetic induction. ]
    Mean arterial pressure (MAP)and heart rate (HR) are measured at baseline, before intubation, and 1, 2, 3, 4, 5 min after intubation.
  • TOF% at intubation [ Time Frame: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection. ]
    neumeric value expressed as %, displayed on the monitor of TOF watch-Sx in TOF stimulation (ex. 5% on the display means 95% suppression of T1)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
  • Roc duration [ Time Frame: participants will be followed when TOF count reaches two, an expected average of 40 min. ]
    Time from Roc injection until TOF = 2 is measured, using ToF-Watch sx.
  • Intubation score [ Time Frame: participants will be followed at the time point of intubation, an expected average of 3 min. ]
    Patients are tracheally intubated, and intubation scores(poor to excellent)are rated.
  • Hemodynamic variables [ Time Frame: participants will be followed for 5 min after the intubation, an expected average of 8 min after the start of anesthetic induction. ]
    Mean arterial pressure (MAP)and heart rate (HR) are measured at 1, 2, 3, 4, 5 min after intubation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Methods to Facilitate Rapid Sequence Intubation
Official Title  ICMJE Comparison of Mg, Ketamine, Large Dose Rocuronium, and Priming on Intubating Condition in Rapid Sequence Intubation
Brief Summary In this study, methods which are known for facilitating rapid sequence intubation or accelerating rocuronium (Roc)onset are compared including magnesium (Mg), ketamine pretreatment, large dose rocuronium and priming.
Detailed Description Patients are pretreated with Mg, ketamine, or priming dose Roc. Two groups do not receive pretreatment, but are given Roc 0.6 mg/kg or 0.9 mg/kg.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Intubating Condition
Intervention  ICMJE
  • Drug: Magnesium Sulfate
    Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.
  • Drug: Ketamine
    patients receive ketamine 0.5 mg/kg 2 min before Roc injection.
  • Drug: rocuronium
    Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.
Study Arms  ICMJE
  • Experimental: ketamine
    Patients receive ketamine 0.5 mg/kg 2 min before Roc injection.
    Intervention: Drug: Ketamine
  • Experimental: priming
    Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.
    Intervention: Drug: rocuronium
  • No Intervention: Roc 0.9
    Patients receive Roc 0.9 mg/kg as an induction dose.
  • No Intervention: Control
    Patients receive Roc 0.6 mg/kg without any pretreatments of Mg, ketamine, or priming.
  • Experimental: Mg
    Patients receive magnesium sulfate (MgSO4) 50 mg/kg over 10 min before Roc injection.
    Intervention: Drug: Magnesium Sulfate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2012)
110
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2011)
150
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 18 - 65 years,
  • ASA 1 - 2,
  • patients scheduled for elective surgery under general anesthesia,
  • BMI 18.5-24.9 kg/m2
  • Mallampati class I-II

Exclusion Criteria:

  • neuromuscular disorder,
  • cardiac/hepatic/renal insufficiency,
  • pregnant.
  • anticipated difficult airway
  • medications that influence neuromuscular transmission
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01479751
Other Study ID Numbers  ICMJE facilitating RSI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kim Mihyun, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mihyun Kim, doctor Seoul National University Bundang Hospital
PRS Account Seoul National University Bundang Hospital
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP