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Completed

NCT Number: NCT04520503

Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol

The induction dose of propofol is generally determined based on patients' characteristics, underlying disease, general condition, and also by clinician's experiences. However, It is difficult to anticipate and objectively calculate an adequate dose of propofol for every patient considering the variability of an individual's response to propofol. If there is a specific pattern in EEG prior to induction of anesthesia that can provide information about the patient's susceptibility to propofol, every induction may be performed far more smoothly with a precisely optimized dose of propofol for each patient. The study is to find a relationship between the pre-induction EEG pattern of adult patients and their sensitivity to propofol.

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Key information

Conditions

Propofol Overdose of Undetermined Intent

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients undergoing general anesthesia

Exclusion criteria

  • Patients undergoing cardiac or brain surgery
  • Patients with neurological deficit or impaired communication (Glasgow Coma Scale < 15)
  • Unstable vital sign (cardiogenic, hemorrhagic, septic shock)
  • Patients with eclampsia
  • Patients who administered preoperative anxiolytics
  • Patients who do not require intubation
  • Patients who are considered unsuitable for the study

Treatment and study plan

Propofol

Drug

The dose of propofol required for loss of consciousness and the total induction dose of propofol will be recorded for every patients.

EEG monitoring

Device

The processed EEG spectrogram and indices, such as patient status index, 95% spectral edge frequency, and suppression ratio, will be obtained from Sedline monitoring device. The raw pre-induction EEG will be extracted from Sedline at the end of induction and it will be analyzed by an external software to calculate the mean frequency, frequency band power and its distribution.

Primary outcomes

  1. Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)

    Time frame: During the induction of anesthesia (up to 15 min)

    Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)

  2. Processed EEG index (PSI; patient state index)

    Time frame: During the induction of anesthesia (up to 15 min)

    Processed EEG index (PSI; patient state index)

  3. Mean frequency and 95% spectral edge frequency (Hz)

    Time frame: During the induction of anesthesia (up to 15 min)

    Mean frequency and 95% spectral edge frequency (Hz)

  4. Burst suppression ratio (%)

    Time frame: During the induction of anesthesia (up to 15 min)

    Burst suppression ratio (%)

Secondary outcomes

  1. The effect-site concentrations of propofol at loss of consciousness (μg/ml)

    Time frame: During the induction of anesthesia (up to 15 min)

    The effect-site concentrations of propofol at loss of consciousness (μg/ml)

  2. The dose of propofol required for loss of consciousness (mg)

    Time frame: During the induction of anesthesia (up to 15 min)

    The dose of propofol required for loss of consciousness (mg)

  3. Total amount of propofol used (mg)

    Time frame: During the induction of anesthesia (up to 15 min)

    Total amount of propofol used (mg)

  4. Time to loss of consciousness (second)

    Time frame: During the induction of anesthesia (up to 15 min)

    Time to loss of consciousness (second) after the start of induction

  5. Vital sign - blood pressure

    Time frame: During the induction of anesthesia (up to 15 min)

    Check blood pressure (mmHg)

  6. Vital sign - heart rate

    Time frame: During the induction of anesthesia (up to 15 min)

    Check heart rate (beats per minute)

  7. Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)

    Time frame: During the induction of anesthesia (up to 15 min)

    Administration of vasopressors (ephedrine (mg), phenylephrine (mcg), epinephrine (mcg), etc)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2020
Registry last updated
Oct 16, 2023

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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