The Relationship Between the SPI and the Postop ED

General Anesthesia Clinical Trial

— SPI_ED  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03328910
• Other study ID #: DCMC#2
• Status: Withdrawn
• Start date: August 2018
• Est. completion date: January 2019

Study information

• Verified date: July 2018
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergence Delirium
• General Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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