NCT04520503|Completed
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Sponsor study identifier
observational
70
1 country
1
Study Start
September 9, 2020
Actual (reported)Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2020
Actual (reported)August 20, 2020
Actual (reported)September 9, 2020
Actual (reported)February 28, 2022
Actual (reported)February 28, 2022
Actual (reported)Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)
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)
Processed EEG index (PSI; patient state index)
Processed EEG index (PSI; patient state index)
During the induction of anesthesia (up to 15 min)
Mean frequency and 95% spectral edge frequency (Hz)
Mean frequency and 95% spectral edge frequency (Hz)
During the induction of anesthesia (up to 15 min)
Burst suppression ratio (%)
Burst suppression ratio (%)
During the induction of anesthesia (up to 15 min)
The effect-site concentrations of propofol at loss of consciousness (μg/ml)
During the induction of anesthesia (up to 15 min)
The dose of propofol required for loss of consciousness (mg)
During the induction of anesthesia (up to 15 min)
Total amount of propofol used (mg)
During the induction of anesthesia (up to 15 min)
Time to loss of consciousness (second)
During the induction of anesthesia (up to 15 min)
Vital sign - blood pressure
During the induction of anesthesia (up to 15 min)
This cohort includes all participants in this study. EEG sensor will be attached to the patient's forehead before induction of anesthesia. Patterns of EEG and data will be obtained
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.
Adult patients, who are aged between 20 and 89 years old, undergoing general anesthesia
Seoul National University Hospital
Seoul, 03080, South Korea
Jin-Tae Kim, PhD
Seoul National University Hospital
70 participants (actual enrollment reported by the registry).
First Submitted
August 5, 2020
First Posted
August 20, 2020
Study Start
September 9, 2020
Actual (reported)Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 28, 2022
Actual (reported)Study Completion
February 28, 2022
Actual (reported)Last Updated
October 16, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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