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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:
ClinicalTrials.gov Identifier:
NCT01720498
First Posted: November 2, 2012
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
  Purpose
To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in elderly patients

Condition Intervention
General Surgery With Endotracheal Intubation Drug: remifentanil

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by So Yeon Kim, Severance Hospital:

Primary Outcome Measures:
  • The effect site concentration for preventing QTc interval prolongation [ Time Frame: 2 min ]

Estimated Enrollment: 50
Study Start Date: October 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: remifentanil
The effect site concentration of 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
Drug: remifentanil
The effect site concentration of remifentanil

Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720498


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Severance Hospital
Investigators
Principal Investigator: So Yeon Kim, MD, PhD Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
  More Information

Responsible Party: So Yeon Kim, Clinical assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01720498     History of Changes
Other Study ID Numbers: 4-2012-0581
First Submitted: October 31, 2012
First Posted: November 2, 2012
Last Update Posted: June 18, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics