Comparison of Methods to Facilitate Rapid Sequence Intubation

Ketamine

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.

Intervention / Treatment

  • Magnesium Sulfate (DRUG)
    Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.
  • Ketamine (DRUG)
    patients receive ketamine 0.5 mg/kg 2 min before Roc injection.
  • Rocuronium (DRUG)
    Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.

Condition or Disease

  • Intubating Condition

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 110 (ACTUAL)
    Funded by: Other
    Allocation: Randomized

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Nov 01, 2011
    Primary Completion: May 01, 2012 ACTUAL
    Completion Date: Aug 01, 2012 ACTUAL
    Study First Posted: Nov 24, 2011 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 24, 2012

    Sponsors / Collaborators

    Lead Sponsor: Seoul National University Bundang Hospital
    Responsible Party: N/A

    Location

    South Korea
    Gyeong-gi Do, South Korea

    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.

    Participant Groups

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

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

    • Patients receive Roc 0.9 mg/kg as an induction dose.

    • Patients receive Roc 0.6 mg/kg without any pretreatments of Mg, ketamine, or priming.

    • Patients receive magnesium sulfate (MgSO4) 50 mg/kg over 10 min before Roc injection.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

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

    Secondary Outcomes

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

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

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

    More Details

    NCT Number: NCT01479751
    Other IDs: facilitating RSI
    Study URL: https://clinicaltrials.gov/study/NCT01479751
    Last updated: Sep 29, 2023