The Relationship Between the SPI and the Postop ED (SPI_ED)

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

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 Overview

• Status: Withdrawn
• Conditions: General Anesthesia
• Intervention / Treatment: Device: SPI monitor (GE Healthcare, Helsinki, Finland)

• Study Type: Observational

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 42472
    • Daegu Catholic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Analgesia monitoring; After anesthesia induction, all participants received standard anesthesia monitoring, SPI monitor (GE Healthcare, Helsinki, Finland) and bispectral index (BIS). BIS was kept between 40-60, whereas no specific target was determined for SPI. At the end of surgery, anesthesia was terminated and the patients were stimulated to wake up. After the participants were able to breathe spontaneously and obey verbal commands, extubation was carefully performed, and the monitoring of SPI was stopped.

Device: SPI 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Observation from approximately 1 hour after the end of operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Observation from approximately 1 hour after the end of operation

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: pulse oximetry; Emergence Delirium; Children, Preschool
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium
• Other Study ID Numbers: DCMC#2

Drug and device information, study documents

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