The Relationship Between the SPI and the Postop ED
- Conditions
- General Anesthesia
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
- 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
Daegu Catholic Medical Center🇰🇷Daegu, Korea, Republic of