Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns

NCT04345926 | Completed Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: OAIC 938/18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Propofol Overdose; EEG

Keywords

Propofol; General anesthesia; EEG; Burst suppression

Outcome Measures

Primary Outcomes (1)

• Change in the alpha power of EEG Spectrogram

  % of change

  Change between baseline time (0 minutes) and burst suppression time (35 minutes)

Secondary Outcomes (3)

• Change in the delta power of EEG Spectrogram

  Change between baseline time (0 minutes) and burst suppression time (35 minutes)

• Change in the coherence

  Change between baseline time (0 minutes) and burst suppression time (35 minutes)

• Change in the propofol concentration

  Change between baseline time (0 minutes) and burst suppression time (35 minutes)

Study Arms (1)

Dose-response

EXPERIMENTAL

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.

Drug: Propofol; Device: Electroencephalogram recording

Interventions

Propofol DRUG

Stepped propofol concentration after 20 min of LOS

Also known as: Dosage increase

Dose-response

Electroencephalogram recording DEVICE

Acquisition of EEG activity

Dose-response

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Chile: lead

Study Sites (2)

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

Santiago, RM, 7690306, Chile

Location

Hospital Clinico de la Universidad de Chile

Santiago, RM, 7690306, Chile

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jose I Egaña, MD/PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Felipe Maldonado, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Rodrigo Gutierrez, MD/PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

• Antonello Penna, MD/PhD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist, MD-PhD

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 15, 2020
• Study Start: August 16, 2018
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CL (2)