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Clinical Trials/NCT03439007
NCT03439007
Completed
Not Applicable

Prediction of Hypotension During Induction of Anesthesia in Pediatric Patients Using Dynamic Variables of Fluid Responsiveness

Seoul National University Hospital1 site in 1 country84 target enrollmentFebruary 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypotension on Induction
Sponsor
Seoul National University Hospital
Enrollment
84
Locations
1
Primary Endpoint
Pleth variability index
Status
Completed
Last Updated
7 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
February 10, 2018
End Date
December 1, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hee-Soo Kim

Prof.

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pleth variability index

Time Frame: changes for 10 minutes

pleth variability index

Secondary Outcomes

  • Adverse event_1(10 minutes)
  • Adverse event_2(10 minutes)
  • Adverse event_3(10 minutes)
  • Adverse event_4(10 minutes)
  • Heart rate(changes for 10 minutes)
  • perfusion index(changes for 10 minutes)
  • pulse oximetry plethysmograpic variance(changes for 10 minutes)

Study Sites (1)

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