The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation Under Propofol-remifentanil Anesthesia in Elderly Patients
This study is currently recruiting participants.
Verified November 2012 by Severance Hospital
Sponsor:
Severance Hospital
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01720498
First received: October 31, 2012
Last updated: November 2, 2012
Last verified: November 2012
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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 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720498
Contacts
| Contact: So Yeon Kim, MD, PhD | 82-2-2227-4470 | KIMSY326@yuhs.ac |
Locations
| Korea, Republic of | |
| Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: So Yeon Kim, MD, PhD 82-2-2227-4470 KIMSY326@yuhs.ac | |
| Principal Investigator: So Yeon Kim, Md, PhD | |
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: | November 2, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Additional relevant MeSH terms:
|
Remifentanil Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 23, 2013