Comparison of Methods to Facilitate Rapid Sequence Intubation

Not Applicable

Completed

• Conditions: Intubating Condition
• Interventions: Drug: Ketamine; Drug: rocuronium; Drug: Magnesium Sulfate

• Registration Number: NCT01479751
• Lead Sponsor: Seoul National University Bundang Hospital

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.

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 Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-23
• Study First Posted: 2011-11-24
• Primary Completion: 2012-05
• Status Verified: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-24
• Last Update Posted: 2012-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine	Ketamine	Patients receive ketamine 0.5 mg/kg 2 min before Roc injection.
priming	rocuronium	Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.
Mg	Magnesium Sulfate	Patients receive magnesium sulfate (MgSO4) 50 mg/kg over 10 min before Roc injection.

Primary Outcome Measures

Name	Time	Method
Intubation score	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 Outcome Measures

Name	Time	Method
Roc duration	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.
Roc onset	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.
Hemodynamic variables	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.
TOF% at intubation	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)

Trial Locations

Locations (1)

Seoul National University Bundang hopital; 🇰🇷 Seongnam, Gyeonggi-Do, Korea, Republic of