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Completed

NCT Number: NCT01479751

Comparison of Methods to Facilitate 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.

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Key information

Conditions

Intubating Condition

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang hopital

Seongnam-si, Gyeonggi-do, 464-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of Mg, Ketamine, Large Dose Rocuronium, and Priming on Intubating Condition in Rapid Sequence Intubation

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 24, 2011
Registry last updated
Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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