The Relationship Between the SPI and the Postop ED

Daegu Catholic University Medical Center

Overview

Surgical plethysmography index (SPI) is a device that can noninvasively monitor the balance between the nociception and ant-nociception using pulse photoplethysmographic amplitude (PPGA) and heart rate obtained through an oxygen saturation measuring device. SPI has recently been studied as a useful tool to monitor the stress response of patients due to surgery or anesthesia and to guide the appropriate use of analgesics/anesthetics. However, these SPI devices have been developed for adults and have not been studied in pediatric patients with relatively high heart rates, and no direct effects on post-operative arousal excitability have been reported.

Study Type

OBSERVATIONAL

Conditions

General Anesthesia

Interventions

SPI monitor (GE Healthcare, Helsinki, Finland)DEVICE

The SPI is derived from pulse rate and pulse wave amplitude measured with photoplethysmography, obtained from the CARESCAPE B650 monitor (GE Healthcare, Finland) with a scale from 1 to 100.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 7 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pediatric patients aged 2-7 years with an American Society of Anaesthesiologists physical status (ASA PS) of 1 or 2, who were planned to undergo ophthalmology surgery requiring general anesthesia. Exclusion Criteria: * ASA PS 3 or 4 * Presence of developmental delays or neurological diseases * History of allergies or contraindications to the use of ketamine (increased intracranial pressure, open-globe injury, or a psychiatric or seizure disorder) * treatment with beta-receptor blockers, beta-receptor agonists or any other drug suspected to interact with the sympathovagal balance * diseases with impairment of sensitivity (diabetes, polyneuropathy, peripheral arterial obstructive disease et etc) * pacemaker therapy * dermal diseases with the affection of the forearm/hand

Locations (1)

Daegu Catholic Medical Center

Daegu, South Korea

Outcomes

Primary Outcomes

Relationship between the SPI during emergence time and the peak emergence delirium score

The SPI is attained from waveform finger plethysmography. It is expressed as a numerical index between 0 (total absence of discomfort) and 100 (high stress level) with an increase after noxious stimulation. We will investigate the relationship between the SPI during emergence period and the pediatric assessment of emergence delirium (PAED) score.

Time frame: Observation from approximately 1 hour after the end of operation

Secondary Outcomes

The sensitivity and specificity of the SPI in detecting the emergence delirium

Receiver operating characteristics (ROC) curves and the associated areas under the curves (AUC) were computed to characterize the sensitivity and specificity of the SPI in detecting a pediatric emergence at different PAED scores.

Time frame: Observation from approximately 1 hour after the end of operation

Data from ClinicalTrials.gov

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