Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia?

Is the Decrease in the Bispectral Index Correlated With a Decrease in Cardiac Output During the Induction of Anaesthesia? A Observational, Single-centre Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02812745

Acronym

BIS1

Enrollment

Registered

2016-06-24

Start date

2015-10-31

Completion date

2017-05-31

Last updated

2018-04-23

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

Conditions

Thoracic Surgery

Keywords

anaesthesia

Brief summary

Monitoring the bispectral index (BIS) as a peri-operative hemodynamic tool appears to be justified by the agreement between various clinical situations in which BIS monitoring appears to be of value: the prognosis in traumatic head injury, the diagnosis of brain death , and the diagnosis of amniotic fluid embolism. The current controversy concerning the triple low state reinforces the need for an accurate study in this field. Furthermore, the recent review by Bidd argues in this sense.

Interventions

DEVICErecording of cardiac output

DEVICEother parameters

BIS (bispectral index ), PI (perfusion index ), etCO2 (end-tidal carbon dioxide ), and brain NIRS (near-infrared spectroscopy)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult (over-18) patients presenting an indication for general anaesthesia during elective cardiac surgery and being monitored for sedation depth * Good echogenicity * Social security coverage

Exclusion criteria

* Pregnancy * Subjects with black skin (a known technical limitation of plethysmography) * Cardiac arrhythmia * Sepsis * Poor echogenicity * Legal guardianship or incarceration * Complications of anaesthesia during induction (anaphylactic shock, cardiac arrest, arrhythmia, or intubation not possible)

Design outcomes

Primary

Measure	Time frame	Description
correlation between variations in the BIS and variations in cardiac output	Day 0	as measured by transthoracic echocardiography

Secondary

Measure	Time frame	Description
correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.	Day 0	measured by transthoracic echocardiography
correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.	Day 0	measured by transthoracic echocardiography
correlation between the cardiac output and the value of brain tissue oxygenation (measured by near-infrared spectroscopy (NIRS)) during the induction of anaesthesia	Day 0	measured by transthoracic echocardiography

Countries

France

Outcome results

None listed

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