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CompletedNCT01479751Updated Aug 27, 2012

Comparison of Methods to Facilitate Rapid Sequence Intubation

An interventional study of Magnesium Sulfate and Ketamine in Intubating Condition, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-08-27.

Sponsored by Seoul National University Bundang Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intubating Condition

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Keywords

  • Rocuronium
  • magnesium
  • priming
  • ketamine
  • intubation
03

In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's enrollment of 110 is above the median of 80 across 732 interventional studies indexed under Disease.

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Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • neuromuscular disorder,
  • cardiac/hepatic/renal insufficiency,
  • pregnant.
  • anticipated difficult airway
  • medications that influence neuromuscular transmission
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    ketamine

    Patients receive ketamine 0.5 mg/kg 2 min before Roc injection.

    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.

    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.

    Drug: Magnesium Sulfate

Interventions

  • DrugMagnesium Sulfate

    Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.

  • DrugKetamine

    patients receive ketamine 0.5 mg/kg 2 min before Roc injection.

  • Drugrocuronium

    Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.

06

What researchers measure

Primary outcomes

  1. Intubation score

    Patients are tracheally intubated, and intubation scores(poor, good,excellent)are rated.

    Time frame: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.

Secondary outcomes

  1. Roc duration

    Time from the start of rocuronium injection until reappearance of two muscle twitches in TOF stimulations is measured, using ToF-Watch sx.

    Time frame: participants will be followed when TOF count reaches two, an expected average of 40 min.

  2. Roc onset

    Time from the start of rocuronium injection until TOF count=0 using TOF-Watch sx.

    Time frame: participants will be followed when TOFcount =0 within an expected average of 4 min from the start of rocuronium injection.

  3. Hemodynamic variables

    Mean arterial pressure (MAP)and heart rate (HR) are measured at baseline, before intubation, and 1, 2, 3, 4, 5 min after intubation.

    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.

  4. TOF% at intubation

    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)

    Time frame: participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.

07

Study locations

1 site
  • Seoul National University Bundang hopital
    Seongnam, Gyeonggi-Do 464-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01479751
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Kim Mihyun (clinical professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Nov 24, 2011
Start date
Nov 2011
Primary completion
May 2012
Completion
Aug 2012
Last update
Aug 27, 2012

Study contacts

Mihyun Kim, doctor
principal investigator · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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