Anesthesia-induced Hypotension and Fluid Responsiveness (PVI)

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

Study Overview

• Status: Completed
• Conditions: Hypotension on Induction

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: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children aged 3-6 years

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hypotensive; A group of pediatric patients who showed hypotension during induction of anesthesia
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	pleth variability index	changes for 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event_1	bradycardia	10 minutes
Adverse event_2	hypotention	10 minutes
Adverse event_3	EEG changes	10 minutes
Adverse event_4	desaturation < 95%	10 minutes
Heart rate	heart rate	changes for 10 minutes
perfusion index	perfusion index	changes for 10 minutes
pulse oximetry plethysmograpic variance	pulse oximetry plethysmograpic variance	changes for 10 minutes

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2018
• Primary Completion (ACTUAL): October 30, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: January 27, 2018
• First Submitted That Met QC Criteria: February 17, 2018
• First Posted (ACTUAL): February 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Dehydration
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 1712-091-907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No