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
  Purpose

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.


Condition Intervention
Intubating Condition
Drug: Magnesium Sulfate
Drug: Ketamine
Drug: rocuronium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Comparison of Mg, Ketamine, Large Dose Rocuronium, and Priming on Intubating Condition in Rapid Sequence Intubation

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 110
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ketamine
Patients receive ketamine 0.5 mg/kg 2 min before Roc injection.
Drug: Ketamine
patients receive ketamine 0.5 mg/kg 2 min before Roc injection.
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
Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.
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
Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01479751

Locations
Korea, Republic of
Seoul National University Bundang hopital
Seongnam, Gyeonggi-Do, Korea, Republic of, 464-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Mihyun Kim, doctor Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Kim Mihyun, clinical professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01479751     History of Changes
Other Study ID Numbers: facilitating RSI
Study First Received: November 22, 2011
Last Updated: August 24, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
Rocuronium
magnesium
priming
ketamine
intubation

Additional relevant MeSH terms:
Ketamine
Magnesium Sulfate
Rocuronium
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Tocolytic Agents
Reproductive Control Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents

ClinicalTrials.gov processed this record on July 10, 2014