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Anesthesia-induced Hypotension and Fluid Responsiveness

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03439007
Acronym
PVI
Enrollment
84
Registered
2018-02-20
Start date
2018-02-10
Completion date
2018-12-01
Last updated
2019-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension on Induction

Keywords

Dehydration

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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pleth variability indexchanges for 10 minutespleth variability index

Secondary

MeasureTime frameDescription
Adverse event_210 minuteshypotention
Adverse event_310 minutesEEG changes
Adverse event_410 minutesdesaturation \< 95%
Adverse event_110 minutesbradycardia
perfusion indexchanges for 10 minutesperfusion index
pulse oximetry plethysmograpic variancechanges for 10 minutespulse oximetry plethysmograpic variance
Heart ratechanges for 10 minutesheart rate

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026