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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00192894
Other study ID # 22-04-0019
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated September 12, 2005
Start date May 2004
Est. completion date March 2005

Study information

Verified date September 2005
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial Summary

The purpose of this study was to evaluate the changes in heart function during onset of spinal anesthesia using a new and less invasive method, the LidcoTMplus.


Description:

The incidence of hypotension during onset of spinal anesthesia in elderly patients varies from 27% to 80% depending on which definition being used. Studies of cardiac output (CO) has shown that it is maintained or only slightly decreased .

Unfortunately, the time-resolution in these studies is often several minutes, and the description of changes is consequently often a start-to-end relation rather than a description of the dynamic changes during onset of spinal anesthesia.

A recent advance in measuring CO is the LiDCOTMplus hemodynamic monitor, which has proved reliable compared to pulmonary artery catheters in various intensive care settings. This monitor allows for beat-to-beat measuring during various procedures and thus early warning of hemodynamic events.

Another method with potential for early warning of decreased perfusion is near-infrared spectroscopy (NIRS). NIRS is used for continuous and non-invasive monitoring of cerebral oxygen saturation (ScO2) and even a small reduction has recently shown to predict maternal hypotension during caesarian section.

The aim of our study was to describe the changes in CO during onset of spinal anesthesia in elderly patients using a method with high time-resolution. We also attempted to evaluate NIRS as predictor of hemodynamic events.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Age 60 years or older

- Elective orthopedic or plastic lower limp surgery

- in spinal anesthesia

Exclusion Criteria:

- Body weight <40 kg

- Currently in treatment with lithium

- Evidence of aortic valve regurgitation

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Department of anaesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Oberstinde Kirsten Jensa la Cours Foundation, The Danish Medical Research Council

Country where clinical trial is conducted

Denmark, 

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