Clinical trial NCT04520503: Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol
Official title: Relationship Between Pre-induction Electroencephalogram Pattern of Adult Patients and Their Sensitivity to Propofol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Propofol Overdose of Undetermined Intent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, who are aged between 20 and 89 years old, undergoing general anesthesia

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.


Eligibility criteria: 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

Primary outcomes:
measure: Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)
timeFrame: During the induction of anesthesia (up to 15 min)
measure: Processed EEG index (PSI; patient state index)
timeFrame: During the induction of anesthesia (up to 15 min)
measure: Mean frequency and 95% spectral edge frequency (Hz)
timeFrame: During the induction of anesthesia (up to 15 min)
measure: Burst suppression ratio (%)
timeFrame: During the induction of anesthesia (up to 15 min)
Secondary outcomes:
measure: The effect-site concentrations of propofol at loss of consciousness (μg/ml)
timeFrame: During the induction of anesthesia (up to 15 min)
measure: The dose of propofol required for loss of consciousness (mg)
timeFrame: During the induction of anesthesia (up to 15 min)
measure: Total amount of propofol used (mg)
timeFrame: During the induction of anesthesia (up to 15 min)
measure: Time to loss of consciousness (second)
timeFrame: During the induction of anesthesia (up to 15 min)
measure: Vital sign - blood pressure
timeFrame: During the induction of anesthesia (up to 15 min)
measure: Vital sign - heart rate
timeFrame: During the induction of anesthesia (up to 15 min)
measure: Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)
timeFrame: During the induction of anesthesia (up to 15 min)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: