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Comparison of Methods to Facilitate Rapid Sequence Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kim Mihyun, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01479751
First received: November 22, 2011
Last updated: August 24, 2012
Last verified: August 2012

November 22, 2011
August 24, 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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01479751
facilitating RSI
Yes
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