The Relationship Between the SPI and the Postop ED

Withdrawn

• Conditions: General Anesthesia
• Interventions: Device: SPI monitor (GE Healthcare, Helsinki, Finland)

• Registration Number: NCT03328910
• Lead Sponsor: Daegu Catholic University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-07-26
• Study Start: 2018-08
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Analgesia monitoring	SPI monitor (GE Healthcare, Helsinki, Finland)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Daegu Catholic Medical Center; 🇰🇷 Daegu, Korea, Republic of