Correlation of Bispectral Index Score and Total Intravenous Anesthesia (TIVA)

Stopped early

Conditions studied: Benign/Malignant Neoplasm, Long Bone Fracture

In brief

General Anesthesia is usually produced by an intravenous agent and then maintained with a breathing agent till the surgery is completed. However, there is a recent trend to produce and maintain general anesthesia solely with an intravenous agent, such as propofol, in view of its advantages. This delivery method is called Total Intravenous Anesthesia (TIVA). The depth of general anesthesia can be measured by an anesthetic depth monitoring device called Bispectral Index (BIS). The use of BIS to determine the depth of anesthesia has been well established whenever a breathing agent is used to maintain general anesthesia. However, the validity of using BIS with TIVA has not been adequately investigated. This study will compare the BIS values at different doses of TIVA in order to establish any correlation between the two. If such a correlation is established, BIS monitoring can safely be recommended to determine anesthetic depth under TIVA.

Key facts

Study ID

NCT01618539

Run by

Rutgers, The State University of New Jersey

People needed

31

Starts

2012-06-01

Expected to finish

2014-09-01

Last updated by the study team

2017-03-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-65 undergoing orthopedic or gyn surgery
• ASA status I-III

You may not qualify if…

• pregnant patients
• uncontrolled hypertension with B/P above 180/100
• unstable angina
• end stage liver or kidney disease
• Pts anticipated to be placed in prone position for surgery
• Documented allergy to propofol, eggs, soy

Where it is running

• University Hospital — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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