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BIS and Entropy Nociception Monitoring

Precise Quantification of Surrogate Nociception Measures Bispectral Index (sBIS)-Electromyography (sEMG) Variabilities and Response Entropy-State Entropy (RE-SE) Difference. A Practice Alignment Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02585466
Acronym
BIS4
Enrollment
50
Registered
2015-10-23
Start date
2008-04-30
Completion date
2010-04-30
Last updated
2015-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

Reports have been appearing in literature over the past years of various nociception-antinociception monitors, introduced and promoted from major manufactures. Recently a new term Practice misalignment has been recently coined indicating research study groups that are distant from daily anesthesia practice, with some scientific relevance but very little clinical relevance simulating purely hypothetical conditions that are not related to everyday anesthesia practice.

Detailed description

Background: Reports have been appearing in literature over the past years of various nociception-antinociception monitors, introduced and promoted from major manufactures. Recently a new term Practice misalignment has been recently coined indicating research study groups that are distant from daily anesthesia practice, with some scientific relevance but very little clinical relevance simulating purely hypothetical conditions that are not related to everyday anesthesia practice. These proposed new nociception-antinociception parameters are assumed to be immune from confounding factors commonly encountered such as neuromuscular block, remifentanil, or cardiovascular haemodynamically active drugs. Methods: Investigators sought to quantify the basic components of these new nociception-antinociception parameters in response to various noxious stimuli, and then test them against the most confounding factors namely neuromuscular blocking agents (NMBAs) for sEMG, remifentanil analgesia and haemodynamic changes, while at the same time analysing the EEG and blood levels. Investigators examined two nociception -antinociception parameters basic components sBIS/sEMG and Response Entropy-State Entropy difference from the two main manufacturers GE and Medtronic. Fifty patients, aged 18-65 years, undergoing general surgery on the lower limb were randomly allocated to the BIS 25 or BIS 50 groups. Exclusion criteria included alcohol or drug abuse, chronic treatment with antihypertensive or cardiovascular medications including β-blockers, and medications acting on the central nervous system such as benzodiazepines, antiepileptic and neuroleptic medications, After capnographic verification of proper lungs ventilation with 40% oxygen in air, either BIS 50 levels or BIS 25 were subsequently maintained via propofol TCI 0.2 microg mL-1 TCI adjustments. Stable BIS values that showed no further decline and remained within BIS ±5 of either BIS 50 levels or BIS 25 of the previous BIS value were considered an indicator of pseudo-steady state plasma effect-site equilibration. Two silver/silver chloride surface stimulating electrodes were placed 4 cm apart on the ulnar nerve at the wrist and connected to Innervator NS272 (Fisher & Paykel, Auckland, New Zealand) peripheral nerve stimulator. The ulnar nerve was stimulated in an ascending sequence of single twitch electric stimulations starting from 10 mA, up till 80 mA for a period of 10 s with a 3 min period between stimulations. BIS and Entropy data were recorded. After which patients were re-stimulated under remifentanil and again re-stimulated under NMBAs.

Interventions

None listed

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1\. age 18-65 years

Exclusion criteria

1. Alcohol or drug abuse, 2. chronic treatment with antihypertensive or cardiovascular medications 3. medications acting on the central nervous system such as benzodiazepines, antiepileptic neuroleptics

Design outcomes

Primary

MeasureTime frameDescription
BIS (Bispectral Index) variability3 minutes following a 10 seconds stimulationBispectral Index (BIS) difference between the highest and lowest values

Secondary

MeasureTime frameDescription
EMG variability3 minutes following a 10 seconds stimulationElectromypgraphy (EMG) difference between the highest and lowest values
Response Entropy - State Entropy difference (RE-SE)3 minutes following a 10 seconds stimulationDifference between Respnse Entropy value (RE, derived from electroencephalography and electromyography) minus State Entropy (SE, derived from electroencephalography only)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026