The Relationship Between the SPI and the Postop ED

NCT ID: NCT03328910

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2019-01-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

SPI monitor (GE Healthcare, Helsinki, Finland)

Intervention Type: 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.

Interventions

SPI monitor (GE Healthcare, Helsinki, Finland)

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daegu Catholic University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Eugene Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Daegu Catholic Medical Center

Daegu, , South Korea

Countries

South Korea

Other Identifiers

DCMC#2

Identifier Type: -

Identifier Source: org_study_id