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Completed

NCT Number: NCT01053611

Composite Variability Index Versus Bispectral Index (BIS)

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).

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Key information

Conditions

Sedation During Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713EZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

propofol + remifentanil 0 ng/ml

Drug

remifentanil 0 ng/ml

propofol + remifentanil 2 ng/ml

Drug

propofol + remifentanil 4 ng/ml

Drug

propofol + remifentanil 6 ng/ml

Drug

Primary outcomes

  1. BIS and CVI.

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2010
Registry last updated
Mar 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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