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NCT01389011 Clinical Trial

Perfusion Index (PI) and Pleth Variability Index (PVI) in Patients With Interscalene Blocks in Orthopedic Surgery

Orthopedic Surgery Clinical Trial

— PI-PVI  

Official title:
An Evaluation of PI and PVI (Masimo) in Patients With Interscalene Blocks in Orthopedic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01389011
Other study ID # AS_001
Secondary ID
Status Completed
Phase N/A
First received July 5, 2011
Last updated September 6, 2011
Start date September 2010

Study information
Verified date July 2011
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority Germany: ethics committee Rheinland-Pfalz
Study type Observational

Clinical Trial Summary

The purpose of this study is to:

1. To describe effects of interscalene nerve blocks on perfusion index (PI) and pleth variability index (PVI) (Radical 7, Masimo Cooperation, Irvine, CA) before and after induction of general anesthesia.

2. To compare effects of fluid-bolusing on PI and PVI of the anesthetized and non-anesthetized limb.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- patients scheduled for shoulder or upper arm surgery

- ASA 1-3

- written informed consent

- approval from the local ethics committee

Exclusion Criteria:

- arrhythmia

- patients suffering from severe vascular disease, coronary artery (CCS IV) disease

- anaemia (haemoglobin < 7mg/dl)

- patients in whom a tidal volume of 8ml/kg cannot be delivered safely

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Anesthesiology, Johannes Gutenberg-University Mainz Mainz Rheinland-Pfalz

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

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