Skip to main content
OpenTrials
Completed

NCT Number: NCT03439007

Anesthesia-induced Hypotension and Fluid Responsiveness

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pleth variability index

    Time frame: changes for 10 minutes

    pleth variability index

Secondary outcomes

  1. Adverse event_1

    Time frame: 10 minutes

    bradycardia

  2. Adverse event_2

    Time frame: 10 minutes

    hypotention

  3. Adverse event_3

    Time frame: 10 minutes

    EEG changes

  4. Adverse event_4

    Time frame: 10 minutes

    desaturation < 95%

  5. Heart rate

    Time frame: changes for 10 minutes

    heart rate

  6. perfusion index

    Time frame: changes for 10 minutes

    perfusion index

  7. pulse oximetry plethysmograpic variance

    Time frame: changes for 10 minutes

    pulse oximetry plethysmograpic variance

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: PVI

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2018
Registry last updated
Apr 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.