CompletedNot Applicable

Comparison of the Skin Conductance Algesimeter and the Nociception Level Index in the Paediatric Population. An Observational Study.

Netherlands50 participantsStarted 2023-09-29

Plain-language summary

Evaluation and comparison of the skin conductance algesimeter(SCA) and the nociception level index(NOL) in the paediatric population (1-12 years) during surgery with general anaesthesia with bispectral index(BIS) in a tertiary hospital in The Netherlands.

Who can participate

Age range1 Year – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female * ASA I, ASA II and ASA III * Aged 1 to 12 years old * Scheduled to undergo elective surgery with general anaesthesia * Written informed consent obtained from subject or/and subject's legal representatives. Exclusion Criteria: * Known allergy to the adhesive tape used in the sensors. * Patients that do not meet the inclusion criteria will be excluded. * No free available limb to attach the probes to.

What they're measuring

Changes in the SCA prior to and during a nociceptive event during the intraoperative period.

Timeframe: Through study completion, an average of 1 year

Changes in the NOL index prior to and during a nociceptive event during the intraoperative period.

Timeframe: Through study completion, an average of 1 year

Correlation between changes in SCA and changes in NOL index during nociceptive events in the intraoperative period.

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT05998564

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-25

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