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NCT02416024 · ClinicalTrials.gov registry record
Arterial Stiffness and General Anesthesia Induced Hypotension in Patients on Angiotensin-converting Enzyme Inhibitors
A clinical trial, sponsored by University of Iowa.
- Completed
- Registry status
- 72
- Enrollment target
NCT02416024: Completed study, sponsored by University of Iowa.
NCT02416024 is a clinical trial that has completed, run by University of Iowa. The registered enrollment target is 72 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02416024 has completed, sponsored by University of Iowa.
- COMPLETED
- Registry status
- 72 participants
- Enrollment target
Study Summary
Induction of general anesthesia to the patient could be a challenging period of anesthesia management. Due to autonomic system suppression, hemodynamic fluctuation, such as hypotension or hypertension, is commonly seen during this period. Furthermore, it has been observed that a fraction of patients who develop hypotension may be refractory to vasoactive medications to attempt to restore the systemic arterial blood pressure back to an acceptable level. Previous studies have shown that patients chronically taking angiotensin converting enzyme (ACE) inhibitors have a higher incidence of developing hypotension under general anesthesia as well as being refractory to adrenergic vasoconstrictor medications given to help restore systemic blood pressure. Interestingly, not all patients taking ACE inhibitors have shown the described hemodynamic response after induction of general anesthesia. Therefore, investigators are attempting to identify what changes in vascular physiology in those patients may contribute to acute refractory systemic hypotension. Specifically, investigators wish to explore whether differences in baseline levels of arterial stiffness potentially contribute to this phenomenon. Arterial applanation tonometry is a non-invasive technique that has been shown to reliably provide indices of arterial stiffness. In the proposed project, applanation tonometry will be performed on the right carotid and femoral arteries to assess carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor system, AtCor Medical, Sydney, Australia) The measurement will be obtained before induction of general anesthesia in the pre-surgical area. During induction of general anesthesia with standard induction agents, brachial blood pressure will be measured by a cuff every minute up to 10 minutes after tracheal intubation. A hypotensive response to anesthesia will be defined by a systolic arterial blood pressure below 90mmHg upon induction. Hypotensive patients th
Primary Outcome
The study is aimed to compare arterial stiffness between patients develop refractory hypotension and do not develop refractory hypotension after administration of anesthetics in preparation for surgery of patients older than 60 years of age and with a prescription/current use of ACE-inhibitors. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor® device (Atcor, Sydney, Australia)
Interventions
- DEVICE SphygmoCor system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2013-08 |
| Est. Completion | 2018-09 |
What the finished NCT02416024 record still lists
NCT02416024 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 72 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which SphygmoCor system is the first listed.
NCT02416024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02416024 about?
NCT02416024 is a clinical study titled "Arterial Stiffness and General Anesthesia Induced Hypotension in Patients on Angiotensin-converting Enzyme Inhibitors". Induction of general anesthesia to the patient could be a challenging period of anesthesia management. Due to autonomic system suppression, hemodynamic fluctuation, such as hypotension or hypertension, is commonly seen during this period. Furthermore, it has been observed that a fraction of patients...
What is the current status of trial NCT02416024?
This trial is currently completed. The enrollment target is 72 participants. The study started on 2013-08. Estimated completion is 2018-09.
What interventions are being tested in trial NCT02416024?
The interventions under investigation include: SphygmoCor system (DEVICE).
Who is sponsoring clinical trial NCT02416024?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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