Surgical Pleth Index- Relevance in Small Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02045810

Acronym

SPIinChildren

Enrollment

Registered

2014-01-27

Start date

2014-01-31

Completion date

2015-03-31

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Measurement, nosiseption

Brief summary

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.

Interventions

DRUGLevobupivacaine

DRUGSaline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

No minimum to 2 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Surgical Pleth Index (SPI) at the time of start of surgery	intraoperative

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026