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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03439007
Other study ID # 1712-091-907
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 10, 2018
Est. completion date December 1, 2018

Study information

Verified date April 2019
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to find out which of the variables related to fluid responsiveness (e. g., perfusion index [PI], pleth variability index [PVI], pulse oximetry plethysmographic variance [ΔPOP]) can best predict hypotension during induction of anesthesia.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date December 1, 2018
Est. primary completion date October 30, 2018
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pleth variability index pleth variability index changes for 10 minutes
Secondary Adverse event_1 bradycardia 10 minutes
Secondary Adverse event_2 hypotention 10 minutes
Secondary Adverse event_3 EEG changes 10 minutes
Secondary Adverse event_4 desaturation < 95% 10 minutes
Secondary Heart rate heart rate changes for 10 minutes
Secondary perfusion index perfusion index changes for 10 minutes
Secondary pulse oximetry plethysmograpic variance pulse oximetry plethysmograpic variance changes for 10 minutes
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