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NCT02045810 Clinical Trial

Surgical Pleth Index- Relevance in Small Children

Anesthesia Clinical Trial

— SPIinChildren  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02045810
Other study ID # JH2013-2
Secondary ID 2013-003607-19
Status Completed
Phase N/A
First received January 22, 2014
Last updated March 13, 2015
Start date January 2014
Est. completion date March 2015

Study information
Verified date March 2015
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Finnish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 2 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Drug:
• Levobupivacaine

• Saline

Locations
Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (1)
Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical Pleth Index (SPI) at the time of start of surgery intraoperative No
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