Surgical Pleth Index- Relevance in Small Children

Surgical Pleth index is a novel device aimed for measurement of intraoperative nosiseption. It has not been tested on small children. The aim of this study is to measure, whether there is a difference in nosiception measured by SPI in a group receiving local anesthetics prior to operation compared to group receiving plasebo.

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Key information

Conditions

Anesthesia

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 33521, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age 0-2 years
Elective surgery planned for inguinal hernia, or testicle retention
Written informed consent from parent received
ASA I-III

Exclusion criteria

Exstrasystolias, known cardiac problem, medication affecting rhytm, allergy to drugs used

Treatment and study plan

Levobupivacaine

Drug

Saline

Drug

Primary outcomes

Surgical Pleth Index (SPI) at the time of start of surgery

Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

Surgical Pleth Index - Relevance in Small Children. A Randomised Double Blinded Study

Acronym: SPIinChildren

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 27, 2014
Registry last updated: Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed