Comparison of Methods to Facilitate Rapid Sequence Intubation

Intubating Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479751
• Other study ID #: facilitating RSI
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: August 24, 2012
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Intubating Condition

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang hopital	Seongnam	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No
Secondary	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.	No
Secondary	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.	Yes
Secondary	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.	No