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

NCT04520503 | Completed

• 1 other identifier: pre-induction EEG
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Propofol Overdose of Undetermined Intent

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (7)

• 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)

Study Arms (1)

Pre EEG group

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

Drug: Propofol; Device: EEG monitoring

Interventions

Propofol DRUG

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

Pre EEG group

EEG monitoring DEVICE

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.

Pre EEG group

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients, who are aged between 20 and 89 years old, undergoing general anesthesia

You may qualify if:

• Adult patients undergoing general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jin-Tae Kim, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (full)

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 20, 2020
• Study Start: September 9, 2020
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

KR (1)