Composite Variability Index Versus Bispectral Index (BIS)

Sedation During Clinical Trial

Official title:

Changes in a Composite Variability Index (CVI) and Bispectral Index (BIS) in Response to Standardized Pain Stimuli During Propofol Remifentanil Infusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053611
• Other study ID #: 2009.083
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: March 24, 2011
• Start date: September 2009
• Est. completion date: September 2010

Study information

• Verified date: September 2009
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the accuracy of the changes in CVI in response to a standardized noxious stimulus during various targeted pseudo-steady-state concentrations of remifentanil and various steady state level of BIS as guided by propofol effect compartment controlled TCI (closed-loop).

Description:

Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol. For remifentanil, concentrations will be targeted at 0, 2, 4 and 6 ng/ml. After an equilibration period, anesthesia will be induced in all patients using propofol in order to reach and maintain a BIS value of 70, 50 or 30. After an equilibration period(from start of propofol infusion), OAA/S will be measured in all patient. All patients will receive a standard pain stimulus (30 seconds, 50 mA) in order to observe the influence of the effect-site concentration of propofol and remifentanil on the CVI. A time window of 5 minutes after the stimulus will be respected to observe the changes in both BIS and CVI. After this period, the study will be terminated and classical maintenance of anesthesia will be provided.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ASA class I and II patients requiring general anesthesia for elective surgical procedures

Exclusion Criteria:

• patient refusal

• weight less than 70% or more than 130% of ideal body weight,

• neurological disorder

• recent use of psycho-active medication, including alcohol.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sedation During

Intervention

Drug:
• propofol + remifentanil 0 ng/ml
remifentanil 0 ng/ml
• propofol + remifentanil 2 ng/ml

• propofol + remifentanil 4 ng/ml

• propofol + remifentanil 6 ng/ml

• propofol + remifentanil 0 ng/ml

• propofol + remifentanil 2 ng/ml

• propofol + remifentanil 6 ng/ml

• propofol + remifentanil 6 ng/ml

• propofol + remifentanil 0 ng/ml

• propofol + remifentanil 2 ng/ml

• propofol + remifentanil 4 ng/ml

• propofol + remifentanil 6 ng/ml

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS and CVI.		2 year	No