Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Severance Hospital:

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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: So Yeon Kim, Clinical assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01720498     History of Changes
Other Study ID Numbers: 4-2012-0581
Study First Received: October 31, 2012
Last Updated: June 16, 2013
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 20, 2014