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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01682707
Other study ID # CAAE-0021.0.185.000-09
Secondary ID
Status Completed
Phase Phase 4
First received April 1, 2010
Last updated September 10, 2012
Start date February 2010
Est. completion date March 2010

Study information

Verified date April 2012
Source Federal University of Juiz de Fora
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria:

- coronary disease ASA 2 e 3 using beta-blockers

Exclusion Criteria:

- emergency surgery arrythmia other antiarrythmic drugs

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
laryngoscopy
tracheal intubation with two different techniques, track light and laryngoscopy.
track light


Locations

Country Name City State
Brazil National Institute of Cardiology / Ministry of Health Rio de Janeiro RJ

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. Portuguese. — View 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. — View 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. Portuguese. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary hemodynamic response tracheal intubation with track light release less adrenergic hormones than laryngoscopy intubation patient prepare (baseline), 1min after induction, 5 min after induction, 1 min after intubation Yes

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