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Clinical Trials/NCT03328910
NCT03328910
Withdrawn
Not Applicable

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

Daegu Catholic University Medical Center1 site in 1 countryAugust 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Anesthesia
Sponsor
Daegu Catholic University Medical Center
Locations
1
Primary Endpoint
Relationship between the SPI during emergence time and the peak emergence delirium score
Status
Withdrawn
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2018
End Date
January 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Daegu Catholic University Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Eugene Kim

Assistant Professor

Daegu Catholic University Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

Relationship between the SPI during emergence time and the peak emergence delirium score

Time Frame: 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 Outcomes

  • The sensitivity and specificity of the SPI in detecting the emergence delirium(Observation from approximately 1 hour after the end of operation)

Study Sites (1)

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