Clinical trial NCT03439007: Anesthesia-induced Hypotension and Fluid Responsiveness
Official title: Prediction of Hypotension During Induction of Anesthesia in Pediatric Patients Using Dynamic Variables of Fluid Responsiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension on Induction
Keywords: Dehydration
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 3-6 years

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.

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

Primary outcomes:
measure: Pleth variability index
timeFrame: changes for 10 minutes
Secondary outcomes:
measure: Adverse event_1
timeFrame: 10 minutes
measure: Adverse event_2
timeFrame: 10 minutes
measure: Adverse event_3
timeFrame: 10 minutes
measure: Adverse event_4
timeFrame: 10 minutes
measure: Heart rate
timeFrame: changes for 10 minutes
measure: perfusion index
timeFrame: changes for 10 minutes
measure: pulse oximetry plethysmograpic variance
timeFrame: changes for 10 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References: