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

Completed

• Conditions: Propofol Overdose of Undetermined Intent
• Interventions: Drug: Propofol; Device: EEG monitoring

• Registration Number: NCT04520503
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-20
• Study Start: 2020-09-09
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-12
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre EEG group	Propofol	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
Pre EEG group	EEG monitoring	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
Vital sign - blood pressure	During the induction of anesthesia (up to 15 min)	Check blood pressure (mmHg)
Vital sign - heart rate	During the induction of anesthesia (up to 15 min)	Check heart rate (beats per minute)
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)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of