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Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns

Primary Purpose

Propofol Overdose, EEG

Status
Completed
Phase
Phase 4
Locations
Chile
Study Type
Interventional
Intervention
Propofol
Electroencephalogram recording
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Propofol Overdose focused on measuring Propofol, General anesthesia, EEG, Burst suppression

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose-response

Arm Description

- Concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL) (LOS time). - Patients will be intubated and remifentanil will be decreased to 4 ng/mL. - Concentration of propofol that caused the LOS will be maintained for 20 minutes (Baseline time). - 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.

Outcomes

Primary Outcome Measures

Change in the alpha power of EEG Spectrogram
% of change

Secondary Outcome Measures

Change in the delta power of EEG Spectrogram
% of change
Change in the coherence
% of change
Change in the propofol concentration
concentration in mcg/mL

Full Information

First Posted
April 7, 2020
Last Updated
April 26, 2021
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT04345926
Brief Title
Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns
Official Title
Determination of Dose-response Curves Between Propofol Concentration and Intraoperative Electroencephalographic Patterns Until Burst Suppression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 16, 2018 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Propofol Overdose, EEG
Keywords
Propofol, General anesthesia, EEG, Burst suppression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose-response
Arm Type
Experimental
Arm Description
- Concentration of propofol at the loss of consciousness (LOS) will be recorded in the presence of remifentanil (7.5 ng/mL) (LOS time). - Patients will be intubated and remifentanil will be decreased to 4 ng/mL. - Concentration of propofol that caused the LOS will be maintained for 20 minutes (Baseline time). - 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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Dosage increase
Intervention Description
Stepped propofol concentration after 20 min of LOS
Intervention Type
Device
Intervention Name(s)
Electroencephalogram recording
Intervention Description
Acquisition of EEG activity
Primary Outcome Measure Information:
Title
Change in the alpha power of EEG Spectrogram
Description
% of change
Time Frame
Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Secondary Outcome Measure Information:
Title
Change in the delta power of EEG Spectrogram
Description
% of change
Time Frame
Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Title
Change in the coherence
Description
% of change
Time Frame
Change between baseline time (0 minutes) and burst suppression time (35 minutes)
Title
Change in the propofol concentration
Description
concentration in mcg/mL
Time Frame
Change between baseline time (0 minutes) and burst suppression time (35 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose I Egaña, MD/PhD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Felipe Maldonado, MD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodrigo Gutierrez, MD/PhD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonello Penna, MD/PhD
Organizational Affiliation
University of Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
7690306
Country
Chile
Facility Name
Hospital Clinico de la Universidad de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
7690306
Country
Chile

12. IPD Sharing Statement

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Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns

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