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

Centre Hospitalier Universitaire, Amiens1 site in 1 country45 target enrollmentOctober 2015

ConditionsThoracic Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Thoracic Surgery
Sponsor: Centre Hospitalier Universitaire, Amiens
Enrollment: 45
Locations: 1
Primary Endpoint: correlation between variations in the BIS and variations in cardiac output
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

May 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire, Amiens

Responsible Party

Sponsor

Eligibility Criteria

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
•Poor echogenicity
•Legal guardianship or incarceration
•Complications of anaesthesia during induction (anaphylactic shock, cardiac arrest, arrhythmia, or intubation not possible)

Outcomes

Primary Outcomes

correlation between variations in the BIS and variations in cardiac output

Time Frame: Day 0

as measured by transthoracic echocardiography

Secondary Outcomes

correlation between cardiac output and end-tidal carbon dioxide (etCO2) during the induction of anaesthesia.(Day 0)
correlation between cardiac output and the perfusion index (PI) during the induction of anaesthesia.(Day 0)
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)