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Comparison of Methods to Facilitate Rapid Sequence Intubation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01479751
First Posted: November 24, 2011
Last Update Posted: August 27, 2012
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.
Information provided by (Responsible Party):
Kim Mihyun, Seoul National University Bundang Hospital
November 22, 2011
November 24, 2011
August 27, 2012
November 2011
May 2012   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01479751 on ClinicalTrials.gov Archive Site
  • 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)
  • 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.
Not Provided
Not Provided
 
Comparison of Methods to Facilitate Rapid Sequence Intubation
Comparison of Mg, Ketamine, Large Dose Rocuronium, and Priming on Intubating Condition in Rapid Sequence Intubation
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intubating Condition
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
August 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01479751
facilitating RSI
Yes
Not Provided
Not Provided
Kim Mihyun, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Not Provided
Principal Investigator: Mihyun Kim, doctor Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
August 2012

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