The Relationship Between the SPI and the Postop ED

NCT03328910 | Withdrawn

• 1 other identifier: DCMC#2
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

Emergence Delirium; pulse oximetry; Children, Preschool

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The sensitivity and specificity of the SPI in detecting the emergence delirium

  Observation from approximately 1 hour after the end of operation

Study Arms (1)

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)

Interventions

SPI monitor (GE Healthcare, Helsinki, Finland) DEVICE

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.

Analgesia monitoring

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

Daegu Catholic Medical Center

Daegu, 42472, South Korea

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 1, 2017
• Study Start: August 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

KR (1)