Clinical trial

the BIS Index Response is Poorly Described by Propofol Effect Site Eleveld's Model After Applying a Perturbation

Name

CEC-SSLR ord: 459

Description

in healthy patients undergoing elective surgery, after a very slow induction, using Eleveld's kinetics as a reference, after loss of consciousness (LOC) and intubation, proceed to infuse propofol until 1% burst suppression ratio is obtained. Then return to the LOC concentration. The BISindex predicted by the model and the real one will be evaluated. The evolution of spectral density frequencies over time will also be evaluated.

Trial arms

Trial start

2013-09-01

Estimated PCD

2023-09-15

Trial end

2024-09-15

Status

Recruiting

Phase

Early phase I

Treatment

fixed propofol infusion 15 mg/kg/h until 1% BSR (burst suppression ratio)

after a slow induction with propofol to loss of consiousness (LOC), we proceed to give remifentanil TCI and rocuronium and intubate the patient. After 5 min we infuse 15 mg/kg/h until 1%BSR observe in the BIS monitor. Then we reduce the TCI LOC predicted concentration.

Arms:

BIS predicted vs real

Size

Primary endpoint

predicted BIS index vs real BIS index

anesthesia

Eligibility criteria

Inclusion Criteria: * ASA I-II patients between 18 and 60 years of age, who undergo elective surgery in the central ward of the Hospital Base San José Osorno, Chile. Consecutive patients from the beginning of the study up to 12 months from the admission of the first patient. Exclusion Criteria: * Emergency surgery patient. * Patients with dementia, delirium or altered state of consciousness. * Full stomach or risk of aspiration. * Allergic to propofol.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'healthy patients proposed for elective surgery longer than 60 min, received a standard protocol TCI iv anesthesia with EEG BIS index monitoring', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

Updated at

2024-05-16

1 organization

1 product

2 indications

Organization

Universidad del Desarrollo

Product

Fixed Propofol Infusion

Indication

Healthy

Indication

Surgery