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The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation in Normotensive and Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT01880931
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital

Brief Summary:
To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients

Condition or disease Intervention/treatment Phase
Intubation, Intratracheal Drug: Remifentanil Not Applicable

Detailed Description:
It is known that anesthetic agents 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 normotensive and hypertensive patients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : June 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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Arm Intervention/treatment
Experimental: Normotensive patients
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: Hypertensive patients
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




Primary Outcome Measures :
  1. The effect site concentration of remifentanil for preventing QTc interval prolongation [ Time Frame: 2 min ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 50 years ASA class I-II female who received surgery with endotracheal intubation

Exclusion Criteria:

  • emergency surgery electrocardiography abnormality diabetes mellitus end stage renal disease moderate to severe cardiac disease moderate to severe liver dysfunction

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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): NCT01880931


Locations
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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
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Principal Investigator: So Yeon Kim, MD, PhD Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

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Responsible Party: So Yeon Kim, Assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01880931     History of Changes
Other Study ID Numbers: 4-2013-0239
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents