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

Propofol Overdose of Undetermined Intent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04520503
• Other study ID #: pre-induction EEG
• Status: Completed
• Start date: September 9, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Hypersensitivity
• Propofol Overdose of Undetermined Intent

Intervention

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

Device:
• EEG monitoring
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute and Relative power in distinct frequency (% d: 1-4 Hz, % ?: 5-8 Hz, % a: 9-12 Hz, % ß: 13-25 Hz)	Relative power in distinct frequency (% d: 1-4 Hz, % ?: 5-8 Hz, % a: 9-12 Hz, % ß: 13-25 Hz)	During the induction of anesthesia (up to 15 min)
Primary	Processed EEG index (PSI; patient state index)	Processed EEG index (PSI; patient state index)	During the induction of anesthesia (up to 15 min)
Primary	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)
Primary	Burst suppression ratio (%)	Burst suppression ratio (%)	During the induction of anesthesia (up to 15 min)
Secondary	The effect-site concentrations of propofol at loss of consciousness (µg/ml)	The effect-site concentrations of propofol at loss of consciousness (µg/ml)	During the induction of anesthesia (up to 15 min)
Secondary	The dose of propofol required for loss of consciousness (mg)	The dose of propofol required for loss of consciousness (mg)	During the induction of anesthesia (up to 15 min)
Secondary	Total amount of propofol used (mg)	Total amount of propofol used (mg)	During the induction of anesthesia (up to 15 min)
Secondary	Time to loss of consciousness (second)	Time to loss of consciousness (second) after the start of induction	During the induction of anesthesia (up to 15 min)
Secondary	Vital sign - blood pressure	Check blood pressure (mmHg)	During the induction of anesthesia (up to 15 min)
Secondary	Vital sign - heart rate	Check heart rate (beats per minute)	During the induction of anesthesia (up to 15 min)
Secondary	Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)	Administration of vasopressors (ephedrine (mg), phenylephrine (mcg), epinephrine (mcg), etc)	During the induction of anesthesia (up to 15 min)