The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01720498
First received: October 31, 2012
Last updated: June 16, 2013
Last verified: June 2013

October 31, 2012
June 16, 2013
October 2012
June 2013   (final data collection date for primary outcome measure)
The effect site concentration for preventing QTc interval prolongation [ Time Frame: 2 min ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01720498 on ClinicalTrials.gov Archive Site
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The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients
Not Provided

To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients

The increase of Corrected QT (QTc) interval is associated with age. It is known that most inhalation anesthetics or intravenous anesthetics can influence the QTc. In addition, tracheal intubation during induction can stimulates sympathetic activity, which, as a results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
General Surgery With Endotracheal Intubation
Drug: remifentanil
The effect site concentration of remifentanil
  • Experimental: Male
    To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method
    Intervention: Drug: remifentanil
  • Experimental: Female
    To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method
    Intervention: Drug: remifentanil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥ 65 years ASA class I-II who received surgery with endotracheal intubation

Exclusion Criteria:

  • emergency surgery
  • electrocardiography abnormality
  • hypertension
  • diabetes mellitus
  • end stage renal disease
  • moderate to severe cardiac disease
  • moderate to severe liver dysfunction
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01720498
4-2012-0581
No
So Yeon Kim, Severance Hospital
Severance Hospital
Not Provided
Principal Investigator: So Yeon Kim, MD, PhD Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Severance Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP