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.

Study Overview

• Status: Completed
• Conditions: Intubating Condition
• Intervention / Treatment: Drug: Ketamine; Drug: rocuronium; Drug: Magnesium Sulfate

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-Do
    • Seongnam, Gyeonggi-Do, Korea, Republic of, 464-707
      • Seoul National University Bundang Hopital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation score	Patients are tracheally intubated, and intubation scores(poor, good,excellent)are rated.	participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roc duration	Time from the start of rocuronium injection until reappearance of two muscle twitches in TOF stimulations is measured, using ToF-Watch sx.	participants will be followed when TOF count reaches two, an expected average of 40 min.
Roc onset	Time from the start of rocuronium injection until TOF count=0 using TOF-Watch sx.	participants will be followed when TOFcount =0 within an expected average of 4 min from the start of rocuronium injection.
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.	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.
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)	participants will be followed at the time point of intubation, an expected average of 70 sec from the start of rocuronium injection.

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Mihyun Kim, doctor, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 24, 2011

Study Record Updates

• Last Update Posted (Estimate): August 27, 2012
• Last Update Submitted That Met QC Criteria: August 24, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: ketamine; intubation; magnesium; Rocuronium; priming
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Neuromuscular Agents; Tocolytic Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Ketamine; Magnesium Sulfate; Rocuronium
• Other Study ID Numbers: facilitating RSI