Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients
Primary Purpose
Coronary Disease Undergoing CABG
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
laryngoscopy
track light
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Disease Undergoing CABG focused on measuring intubation, coronary disease, hemodynamic response, anesthesia with tracheal intubation, assessment of hemodynamic response
Eligibility Criteria
Inclusion Criteria:
- coronary disease ASA 2 e 3 using beta-blockers
Exclusion Criteria:
- emergency surgery arrythmia other antiarrythmic drugs
Sites / Locations
- National Institute of Cardiology / Ministry of Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laryngoscopy
Track Light
Arm Description
Laryngoscopy Track Light teaqueal intubation
Outcomes
Primary Outcome Measures
hemodynamic response
tracheal intubation with track light release less adrenergic hormones than laryngoscopy intubation
Secondary Outcome Measures
Full Information
NCT ID
NCT01682707
First Posted
April 1, 2010
Last Updated
September 10, 2012
Sponsor
Federal University of Juiz de Fora
1. Study Identification
Unique Protocol Identification Number
NCT01682707
Brief Title
Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients
Official Title
Randomized Clinical Trials to Compare the Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients Undergoing CABG
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Juiz de Fora
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Opioids provide greater patient comfort during intubation, but are not able to abolish completely the release adrenergic hormones during the laryngoscopy, which may cause undesirable hemodynamic changes.
In this study the investigators selected two techniques commonly used for intubation, laryngoscopy and track light, so the investigators can verify which intubation techniques provides less hemodynamic changes in coronary patients under standard anesthesia induction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease Undergoing CABG
Keywords
intubation, coronary disease, hemodynamic response, anesthesia with tracheal intubation, assessment of hemodynamic response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laryngoscopy
Arm Type
Active Comparator
Arm Description
Laryngoscopy Track Light teaqueal intubation
Arm Title
Track Light
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
laryngoscopy
Other Intervention Name(s)
rigidy laryngoscopy,
Intervention Description
tracheal intubation with two different techniques, track light and laryngoscopy.
Intervention Type
Procedure
Intervention Name(s)
track light
Primary Outcome Measure Information:
Title
hemodynamic response
Description
tracheal intubation with track light release less adrenergic hormones than laryngoscopy intubation
Time Frame
patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coronary disease ASA 2 e 3 using beta-blockers
Exclusion Criteria:
emergency surgery arrythmia other antiarrythmic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcello F Salgado filho, MD
Organizational Affiliation
Federal University of Juiz de Fora
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cardiology / Ministry of Health
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22240-005
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
12208438
Citation
Nishiyama T, Misawa K, Yokoyama T, Hanaoka K. Effects of combining midazolam and barbiturate on the response to tracheal intubation: changes in autonomic nervous system. J Clin Anesth. 2002 Aug;14(5):344-8. doi: 10.1016/s0952-8180(02)00370-7.
Results Reference
background
PubMed Identifier
19466360
Citation
Nora FS, Klipel R, Ayala G, Oliveira Filho GR. [Remifentanil: does the infusion regimen make a difference in the prevention of hemodynamic responses to tracheal intubation?]. Rev Bras Anestesiol. 2007 Jun;57(3):247-60. doi: 10.1590/s0034-70942007000300003. Portuguese.
Results Reference
result
PubMed Identifier
19471727
Citation
Almeida MC, Martins RS, Martins AL. [Tracheal intubation conditions at 60 seconds in children, adults and elderly patients.]. Rev Bras Anestesiol. 2004 Apr;54(2):204-11. doi: 10.1590/s0034-70942004000200007. Portuguese.
Results Reference
result
Links:
URL
http://www.sba.com.br
Description
Sociedade brasileira de Anestesiologia
URL
http://www.ufjf.edu.br
Description
Related Info
URL
http://www.inc.saude.gov.br
Description
Related Info
URL
http://www.scahq.org
Description
Related Info
URL
http://bja.oxfordjournals.org
Description
Related Info
Learn more about this trial
Assessment of Hemodynamic Response During Intubation Between Rigid Laryngoscopy and Track Light in Coronary Patients
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