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Completed

NCT Number: NCT04345926

Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns

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.

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Key information

Conditions

Propofol Overdose EEG

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Stepped propofol concentration after 20 min of LOS

Other names: Dosage increase

Electroencephalogram recording

Device

Acquisition of EEG activity

Primary outcomes

  1. Change in the alpha power of EEG Spectrogram

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

    % of change

Secondary outcomes

  1. Change in the delta power of EEG Spectrogram

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

    % of change

  2. Change in the coherence

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

    % of change

  3. Change in the propofol concentration

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

    concentration in mcg/mL

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Determination of Dose-response Curves Between Propofol Concentration and Intraoperative Electroencephalographic Patterns Until Burst Suppression

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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