Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns

NCT ID: NCT04345926

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-16
• Study Completion Date: 2020-02-26

Brief Summary

In the world, 230 million surgeries are performed per year and a significant part is performed in patients over 65 years of age. These patients are more labile, especially from the neurocognitive point of view with a high risk to develop neurocognitive complications, such as postoperative delirium. Recent studies have linked this type of complication with an overdose of general anesthetics during surgery. For this reason, in recent years, the use of brain function monitors during the intraoperative period has been recommended to adapt the dosage of the drugs to each patient and thus to avoid overdosing of general anesthetics. However, to date, the available monitors that process the electroencephalographic signal are not able to adequately discriminate gradual changes in anesthetic depth. Also, no systematic studies have been performed that analyze changes that occur in the electroencephalogram (EEG) signal secondary to increases in complications from general anesthetics. Thus, the investigators design this study with the main aim to determine the changes in electroencephalographic patterns induced by a stepped increase of propofol until the burst suppression is reached.

Detailed Description

The investigators will carry out a prospective analytical observational clinical study at the Clinical Hospital of the University of Chile. In total 15 patients will be recruited, in who a frontal electroencephalographic signal will be recorded using a SedLine® monitor, and propofol concentration will be estimated using the Marsh model. First, the concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL). Then, patients will be intubated and remifentanil will be decreased to 4 ng/mL. After that, the concentration of propofol that caused the LOS will be maintained for 20 minutes. Finally, propofol will be increased in steps of 0.3 mcg/mL for 7 min, until an episode of burst suppression will be observed. In the complete protocol, EEG activity will be acquired using a SedLine® monitor.

Conditions

Propofol Overdose; EEG

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Dose-response

1. - Concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL) (LOS time).

2. - Patients will be intubated and remifentanil will be decreased to 4 ng/mL.

3. - Concentration of propofol that caused the LOS will be maintained for 20 minutes (Baseline time).

4. - Propofol will be increased in steps of 0.3 mcg/mL for 7 minutes until an episode of burst suppression will be observed (Burst suppression time).

EEG activity will be acquired using a SedLine® monitor during the complete protocol.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Stepped propofol concentration after 20 min of LOS

Electroencephalogram recording

Intervention Type: DEVICE

Acquisition of EEG activity

Interventions

Propofol

Stepped propofol concentration after 20 min of LOS

Intervention Type: DRUG

Electroencephalogram recording

Acquisition of EEG activity

Intervention Type: DEVICE

Other Intervention Names

Dosage increase

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) Physical Status 1 or 2
• Low-risk surgery

Exclusion Criteria

• BMI > 35 kg/m2
• Benzodiazepines use
• Epilepsy
• Psychiatric disorder
• Kidney disease
• Liver disease
• Brain damage

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Antonello Penna

Principal Investigator, Anesthesiologist, MD-PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose I Egaña, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Felipe Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Rodrigo Gutierrez, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Antonello Penna, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Chile

Locations

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

Santiago, RM, Chile

Hospital Clinico de la Universidad de Chile

Santiago, RM, Chile

Countries

Chile

Other Identifiers

OAIC 938/18

Identifier Type: -

Identifier Source: org_study_id