The Relationship Between the SPI and the Postop ED

The Relationship Between the Surgical Pleth Index (SPI) and the Postoperative Emergence Delirium in Pediatric Patients After General Anesthesia

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03328910

Acronym

SPI_ED

Enrollment

Registered

2017-11-01

Start date

2018-08-31

Completion date

2019-01-31

Last updated

2018-07-26

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

Conditions

General Anesthesia

Keywords

Emergence Delirium, pulse oximetry, Children, Preschool

Brief summary

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.

Interventions

DEVICESPI monitor (GE Healthcare, Helsinki, Finland)

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 7 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Relationship between the SPI during emergence time and the peak emergence delirium score	Observation from approximately 1 hour after the end of operation	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.

Secondary

Measure	Time frame	Description
The sensitivity and specificity of the SPI in detecting the emergence delirium	Observation from approximately 1 hour after the end of operation	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.

Countries

South Korea

Outcome results

None listed

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