NCT01479751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 27, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

November 22, 2011

Last Update Submit

August 24, 2012

Conditions

Intubating Condition

Keywords

Rocuroniummagnesiumprimingketamineintubation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Roc duration

    participants will be followed when TOF count reaches two, an expected average of 40 min.

  • Roc onset

    participants will be followed when TOFcount =0 within an expected average of 4 min from the start of rocuronium injection.

  • 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.

  • 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.

Study Arms (5)

ketamine

EXPERIMENTAL

Patients receive ketamine 0.5 mg/kg 2 min before Roc injection.

Drug: Ketamine

priming

EXPERIMENTAL

Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.

Drug: rocuronium

Roc 0.9

NO INTERVENTION

Patients receive Roc 0.9 mg/kg as an induction dose.

Control

NO INTERVENTION

Patients receive Roc 0.6 mg/kg without any pretreatments of Mg, ketamine, or priming.

Mg

EXPERIMENTAL

Patients receive magnesium sulfate (MgSO4) 50 mg/kg over 10 min before Roc injection.

Drug: Magnesium Sulfate

Interventions

Magnesium SulfateDRUG

Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.

Mg
KetamineDRUG

patients receive ketamine 0.5 mg/kg 2 min before Roc injection.

ketamine
rocuroniumDRUG

Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.

priming

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • neuromuscular disorder,
  • cardiac/hepatic/renal insufficiency,
  • pregnant.
  • anticipated difficult airway
  • medications that influence neuromuscular transmission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang hopital

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

Location

MeSH Terms

Interventions

Magnesium SulfateKetamineRocuronium

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsAndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Mihyun Kim, doctor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 24, 2011

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

August 27, 2012

Record last verified: 2012-08

Locations

KR(1)