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

NCT01618539 | Terminated

• 1 other identifier: 2011001109
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign/Malignant Neoplasm; Long Bone Fracture

Keywords

Total intravenous anesthesia, Bispectral Index Score

Outcome Measures

Primary Outcomes (1)

• BIS response to varying TIVA dosages

  Correlation between various infusion rates of propofol administered during TIVA and BIS values during the first 3 hours of the operative procedure

  3 hours

Interventions

propofol DRUG

varying intravenous dosages

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

male and female

You may qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Steven Shulman, MD

  Rutgers/NJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 13, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 14, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)