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The Influence of Age on Bispectral Index Associated With Propofol-induced Sedation

NCT02046720 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-03-23

No results posted yet for this study

Summary

The bispectral index (BIS) is commonly used in anesthesia to evaluate the depth of sedation. Numerous studies in adults have shown good correlation between bispectral index values and depth of sedation regardless of the hypnotic drug used. Requirements of intravenous and inhalational hypnotic agents to suppress consciousness decrease with age. A study showed that the loss of consciousness (LOC) was obtained with lower concentrations of sevoflurane in elderly than in young adults, but at identical BIS values, so that BIS would predict depth of sedation better than drug monitoring. This result incited the use of bispectral index monitoring to overcome the significant pharmacological variability, especially in elderly. Nevertheless, another research with a comparable methodology during propofol-induced anaesthesia provided higher BIS values at LOC in elderly compared to younger patients. In these two trials, LOC was defined differently: either by absence of verbal response corresponding to loss of eyelash reflex (LOER) or by absence of response to prodding \[(OAA/S) \<2)\]. Otherwise electromyographic activity (EMG) was not taken in account. As high EMG level (greater than 50 decibels) could create subtle artifact signal pollution without necessarily being displayed as artifacts, this would be misinterpreted by the BIS algorithm as EEG activity and assigned a spuriously increased BIS value.

The main objective of our study was to specifically evaluate BIS values according to age during propofol-induced sedation. LOC was measured by obtaining an OAA/S score \<2 (OAA/S2), or a deeper sedation criterion: loss of eyelash reflex (LOER). The secondary objective was to specify the influence of EMG on the displayed BIS values and its age-related modifications.

Conditions

  • Anesthesia

Interventions

DRUG

Propofol induced sedation

Propofol was administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider (Base Primea , Fresenius-Kabi, Brezins, FRANCE)12. The initial effect-site target concentration of propofol (0.5 μg/ml) was incremented by 0.5 μg/ml every 5 minutes to ensure equilibration between plasma concentration and effect site, until loss of eyelash reflex. From the beginning of infusion until LOER patients received no other agent besides propofol for the duration of the trial. The BIS index was compared between a young population (18 to 64 years old) and an elderly population (65 and more)

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Sylvie PASSOT, MD · CHU de Saint-Etienne

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02046720 on ClinicalTrials.gov