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

October 12, 2023 updated by: Jin-Tae Kim, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute and Relative power in distinct frequency (% δ: 1-4 Hz, % θ: 5-8 Hz, % α: 9-12 Hz, % β: 13-25 Hz)
Time Frame: 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)
During the induction of anesthesia (up to 15 min)
Processed EEG index (PSI; patient state index)
Time Frame: During the induction of anesthesia (up to 15 min)
Processed EEG index (PSI; patient state index)
During the induction of anesthesia (up to 15 min)
Mean frequency and 95% spectral edge frequency (Hz)
Time Frame: During the induction of anesthesia (up to 15 min)
Mean frequency and 95% spectral edge frequency (Hz)
During the induction of anesthesia (up to 15 min)
Burst suppression ratio (%)
Time Frame: During the induction of anesthesia (up to 15 min)
Burst suppression ratio (%)
During the induction of anesthesia (up to 15 min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect-site concentrations of propofol at loss of consciousness (μg/ml)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: During the induction of anesthesia (up to 15 min)
Time to loss of consciousness (second) after the start of induction
During the induction of anesthesia (up to 15 min)
Vital sign - blood pressure
Time Frame: During the induction of anesthesia (up to 15 min)
Check blood pressure (mmHg)
During the induction of anesthesia (up to 15 min)
Vital sign - heart rate
Time Frame: During the induction of anesthesia (up to 15 min)
Check heart rate (beats per minute)
During the induction of anesthesia (up to 15 min)
Administration of vasopressors (ephedrine, phenylephrine, epinephrine, etc)
Time Frame: During the induction of anesthesia (up to 15 min)
Administration of vasopressors (ephedrine (mg), phenylephrine (mcg), epinephrine (mcg), etc)
During the induction of anesthesia (up to 15 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin-Tae Kim, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2020

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pre-induction EEG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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