Surgical Pleth Index- Relevance in Small Children

NCT ID: NCT02045810

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Treatment

Patients in group receive Ileoinguinal block before the start of surgery, and an injection of plasebo saline after surgery. Injectate is blinded from caregiver.

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Saline

Intervention Type DRUG

Control group

Patients receive a plasebo saline injetion at the site of ileoinguinal block prior to surgery and an injectio with local anesthetics after surgery. The treatment group is blinded for caregiver.

Group Type PLACEBO_COMPARATOR

Levobupivacaine

Intervention Type DRUG

Saline

Intervention Type DRUG

Interventions

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Levobupivacaine

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jarkko Harju, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Arvi Yli-Hankala, Prof, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

References

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Harju J, Kalliomaki ML, Leppikangas H, Kiviharju M, Yli-Hankala A. Surgical pleth index in children younger than 24 months of age: a randomized double-blinded trial. Br J Anaesth. 2016 Sep;117(3):358-64. doi: 10.1093/bja/aew215.

Reference Type DERIVED
PMID: 27543530 (View on PubMed)

Other Identifiers

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2013-003607-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

JH2013-2

Identifier Type: -

Identifier Source: org_study_id

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