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

NCT02046720 | Completed Phase 3

• 1 other identifier: 1008181
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Bispectral Index (BIS) values

  Electroencephalographic activity was monitored by BIS Quatro XP platform® electrodes and a BIS VISTA™ 1.01 monitor (Aspect medical system, MA, USA). The impedance of each electrode was kept below 5 kΩ. The sensor were reapplied if the quality of the detected signal was not suitable to provide a reliable BIS score i.e a signal quality index (SQI) better than 50%. The trace was displayed in real time and calculated data (BIS) were recorded continuously using the archiving function integrated in the monitor. A 30 second smoothing period was set to minimize the variability and sensitivity of artifacts. BIS values were validated throughout the trial by SQI values greater than 90.

  loss of consciousness (LOC), approximatively 20 to 30 minutes after the beginning of anesthesia

Secondary Outcomes (1)

• the EMG component of the bispectral index value

  loss of consciousness approximatively 20 to 30 minutes after the beginning of anesthesia

Study Arms (1)

propofol induced sedation

EXPERIMENTAL

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.

Drug: Propofol induced sedation

Interventions

Propofol induced sedation DRUG

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)

Also known as: PIS

propofol induced sedation

Eligibility Criteria

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

You may qualify if:

• patients over 18 years
• ASA I to III
• scheduled to undergo orthopaedic surgery under general anaesthesia

You may not qualify if:

• presence of heart, respiratory, hepatic or renal failure
• psychiatric or neurological pathology
• severe depression or dementia
• gastro-oesophageal reflux
• hiatal hernia
• drug addiction or chronic alcoholism
• obesity with a body mass index greater than 30

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

Study Officials

• Sylvie PASSOT, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 28, 2014
• Study Start: June 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 23, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)