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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04520503
Enrollment
70
Registered
2020-08-20
Start date
2020-09-09
Completion date
2022-02-28
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Propofol Overdose of Undetermined Intent

Brief summary

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.

Interventions

DRUGPropofol

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

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)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)
Processed EEG index (PSI; patient state index)During the induction of anesthesia (up to 15 min)Processed EEG index (PSI; patient state index)
Mean frequency and 95% spectral edge frequency (Hz)During the induction of anesthesia (up to 15 min)Mean frequency and 95% spectral edge frequency (Hz)
Burst suppression ratio (%)During the induction of anesthesia (up to 15 min)Burst suppression ratio (%)

Secondary

MeasureTime frameDescription
Vital sign - blood pressureDuring the induction of anesthesia (up to 15 min)Check blood pressure (mmHg)
The effect-site concentrations of propofol at loss of consciousness (μg/ml)During the induction of anesthesia (up to 15 min)The effect-site concentrations of propofol at loss of consciousness (μg/ml)
Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)During the induction of anesthesia (up to 15 min)Administration of vasopressors (ephedrine (mg), phenylephrine (mcg), epinephrine (mcg), etc)
Vital sign - heart rateDuring the induction of anesthesia (up to 15 min)Check heart rate (beats per minute)
The dose of propofol required for loss of consciousness (mg)During the induction of anesthesia (up to 15 min)The dose of propofol required for loss of consciousness (mg)
Total amount of propofol used (mg)During the induction of anesthesia (up to 15 min)Total amount of propofol used (mg)
Time to loss of consciousness (second)During the induction of anesthesia (up to 15 min)Time to loss of consciousness (second) after the start of induction

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026