- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03439007
Anesthesia-induced Hypotension and Fluid Responsiveness (PVI)
Prediction of Hypotension During Induction of Anesthesia in Pediatric Patients Using Dynamic Variables of Fluid Responsiveness
Study Overview
Status
Conditions
Detailed Description
Propofol is a widely used intravenous agent for induction of anesthesia in children aged 3 years and more. A well-known adverse effect of propofol is hypotension, which can be properly dealt with hydration and/or administration of inotropics and vasopressors. However, severe hypotension during anesthetic induction may not be immediately cured if anesthesiologist should concentrate on ventilation of the patient. Since pediatric patients have smaller reservoir for oxygen supply and perfusion to various organs of the body, delayed handling of severe hypotension may result in irreversible damage to the vital organs.
Hypotension during anesthesia is caused, though not entirely, by dehydration. There are a variety of non-invasive variables that are related to the severity of dehydration, but which of the variables can best predict anesthesia-induced hypotension in pediatric patients. In this study, we will measure the preoperative values of non-invasive variables related to fluid status, and find out which of them are most closely related to the occurrence of hypotension during anesthesia induction.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children aged 3-6 years
- Scheduled to undergo elective surgery under general anesthesia
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status classification III or more
Contraindication of laryngeal mask airway (LMA) insertion:
(1) Esophagitis, gastritis, peptic ulcer, pyloric or intestinal stenosis, history of upper gastrointestinal tract surgery, body mass index [BMI] > 30, expected anesthesia time > 2 hours)
- Arrhythmia
- Left ventricular failure (ejection fraction < 40%)
- Congenital syndromes which are known to affect cardiopulmonary function
- Use of inotropics/vasopressors before anesthesia
- History of allergic reaction to drugs used in general anesthesia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hypotensive
A group of pediatric patients who showed hypotension during induction of anesthesia
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Normotensive
A group of pediatric patients who did not show hypotension during induction of anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pleth variability index
Time Frame: changes for 10 minutes
|
pleth variability index
|
changes for 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event_1
Time Frame: 10 minutes
|
bradycardia
|
10 minutes
|
Adverse event_2
Time Frame: 10 minutes
|
hypotention
|
10 minutes
|
Adverse event_3
Time Frame: 10 minutes
|
EEG changes
|
10 minutes
|
Adverse event_4
Time Frame: 10 minutes
|
desaturation < 95%
|
10 minutes
|
Heart rate
Time Frame: changes for 10 minutes
|
heart rate
|
changes for 10 minutes
|
perfusion index
Time Frame: changes for 10 minutes
|
perfusion index
|
changes for 10 minutes
|
pulse oximetry plethysmograpic variance
Time Frame: changes for 10 minutes
|
pulse oximetry plethysmograpic variance
|
changes for 10 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1712-091-907
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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