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The Relationship Between the SPI and the Postop ED (SPI_ED)

D

Daegu Catholic University Medical Center

Status

Withdrawn

Conditions

General Anesthesia

Treatments

Device: SPI monitor (GE Healthcare, Helsinki, Finland)

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

2 to 7 years old

Volunteers

No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Analgesia monitoring
Description:
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.
Treatment:
Device: SPI monitor (GE Healthcare, Helsinki, Finland)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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