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AnesthesiologyNCT06703879

Machine Learning-Based Model for Individualized Drug Dose Prediction for Propofol

An observational study of Anesthesiology and Anesthesiology Management, run by General Hospital of Ningxia Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to develop an individualized prediction model for drug dosage during propofol-induced loss of consciousness in anticipation of advances in research in this area. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Anesthesiology, Anesthesiology Management
What is being tested?
Anesthesia induction with propofol
Type of treatment
Injection or infusion
How many people
1,200 participants
Where
1 siteChina
Study dates
20 Nov 2024to 30 Jul 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Inpatients requiring elective surgery or outpatient painless endoscopic surgery; Induction of anesthesia with propofol

Who may be able to join

  • Inpatients requiring elective surgery or outpatient painless endoscopic surgery; Induction of anesthesia with propofol; Age≥18 years old; ASA classifications I-III

Who cannot join

  • Propofol allergy; Contraindication to anesthesia; Declined to participate in the study

Trial locations and contacts

1 site in 1 country.

China1 site
  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

Other trials in China

About this study

Official title: A Machine Learning-Based Model for Individualized Drug Dose Prediction for Propofol-Induced Loss of Consciousness in Patients

The goal of this observational study is to develop an individualized prediction model for drug dosage during propofol-induced loss of consciousness in anticipation of advances in research in this area. An appropriate delivery model to reduce perianesthesia complications in patients, especially in outpatient painless endoscopy patients. The main question it aims to answer is:

What type of machine learning algorithm should be used to build a drug dose prediction model that is suitable for patient awareness of anesthesia induction? 1000 participants routinely with propofol induced anesthesia loss of consciousness included in this study.

Read the detailed description

Study Methods:

(1)Case selection: Patients requiring elective surgical treatment in the Cardiovascular and Cerebrovascular Disease Hospital of General Hospital of Ningxia Medical University.

Inclusion criteria: Patients were gender-neutral and aged ≥18 years.

(2) Clinical study protocol: Patients were admitted to the operating room to establish intravenous access, connected to ECG monitoring, EEG monitoring, 4L/min mask oxygenation, and real-time video recording of the entire anesthesia induction process using a video recorder for postoperative integration of various data. Propofol was pumped in at 100 mg/kg/h, and the anesthesiologist with propofol assessed the degree of sedation of the patient until the patient was deeply sedated and the MOAA/S score was 0, and the pumping of propofol was stopped.

(3) Observation indicators: Demographic information and general preoperative data were collected, including patients' gender, age, weight, height, ASA classification, body mass index (BMI), and past medical history (hypertension, coronary heart disease, diabetes mellitus, respiratory disease, stroke).

Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, finger pulse oximetry (SPO2), electroencephalogram waveforms, the dosage of propofol administered from the start of anesthesia induction to MOAA/S = 0, and the time of administration of propofol were recorded for all the basic and extended monitoring parameters, respectively, after the patient was admitted to the operating room and at the time of the 0 score of the MOAA/S score.

(4) Evaluation methods of each item Depth of anesthesia assessment: MOAA/S depth of sedation was used for assessment, and MOAA/S score of 4-5 was classified as mild sedation, which indicated that the response to calling names in normal tone was sensitive or slow; 2-3 was classified as moderate sedation, which indicated that there was a response to calling names loudly or repeatedly, or there was a response to slight pushing and vibration; ≤1 was classified as deep sedation, which indicated that there was a response to pain stimulation; 0 was classified as general anesthesia, which indicated that there was a response to pain stimulation; 0 was classified as general anesthesia, which indicated that there was a response to pain stimulation. ≤1 is classified as deep sedation, indicating a response to painful stimuli; 0 is classified as general anesthesia, indicating no response to painful stimuli.

EEG feature extraction: use python MNE (https://mne.tools/stable/index.html) module package for analysis, MNE can read most common physiological signals in raw data format, the specific methods are as follows: ① Data extraction: import data → electrode positioning → reject useless electrodes → re-reference → filter → drop sampling rate → run ICA → batch processing → segmentation and baseline correction → interpolation of bad conductance and rejection of bad conductance → removal of noise components → rejection of bad segments; ② Data division: the data of the required EEG monitoring points are divided to include wakefulness and sedation; ③ Feature extraction: time domain, amplitude square root value, kurtosis, skewness, burst suppression rate/minute, frequency domain, and entropy index are obtained by Fourier transform.

(5) Proposed machine learning algorithm: regression analysis is a predictive modeling technique that works from a set of data to determine quantitative relational equations between certain variables, statistically test these relational equations between the variables, and identify the variables that have a significant effect from among the multiple variables that affect a particular variable.

Being tested
Anesthesia induction with propofol
Keywords
machine learning, propofol-induced loss of consciousness in patients, predict model

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anesthesia induction with propofolDrug

    Also called Induction of anesthesia by intravenous infusion of propofol

    Establishment of a database of clinical characteristics of propofol-induced loss of consciousness in patients with complete clinical information Acquisition of basic perioperative monitoring data and extended monitoring data: 1,000 patients aged ≥18 years who needed to undergo surgical treatment were included (according to the machine learning diagnosis results, if the poor model fit was due to the small sample size, the necessary number of samples could be continued to be collected), and perioperative monitoring and management of the patients was performed, and a video recorder was used to videotape the whole anesthesia induction process in real time, so as to facilitate the postoperative integration of various data. The basic characteristics of the patients and the perioperative monitoring characteristics were extracted from the surgical anesthesia recording system, including gender, age, height, weight, blood pressure, ASA classification, electroencephalographic parameters, the a

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug dosage of propofol for inducing loss of consciousness in patients

    Propofol was pumped at 100 mg/kg/h. The anesthesiologist assessed the patient's sedation level with the MOAA/S scale until the patient was deeply sedated and the MOAA/S score was less than or equal to 1, and pumping of propofol was stopped.

    Propofol Continuous Pumping Volume Recorded(mg). Record propofol pumping duration.

    Measured: through study completion, an average of six months

Secondary outcomes (3)
  1. Relevant factors that can influence the intravenous dose of propofol

    Demographic information and general preoperative data were collected, including the patient's sex, age, weight, height, ASA classification, body mass index (BMI), and past medical history (hypertension, coronary artery disease, diabetes mellitus, respiratory disease, stroke).

    Measured: through study completion, an average of six months

  2. Patient's peri-anesthetic vital signs

    Systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, and finger pulse oximetry (SPO2) were recorded after the patient was admitted to the operating room and at a MOAA/S score of 0, respectively.

    Measured: through study completion, an average of six months

  3. Characteristics of the patient's perianesthesia electroencephalogram

    EEG waveforms were recorded during the patient's perianesthesia period using an EEG monitor to mark the EEG characteristics during wakefulness and MOAA/S less than or equal to 1.

    Measured: through study completion, an average of six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start20 Nov 2024
  3. Primary completion30 Mar 2025
  4. Study completion30 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,200 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06703879
Sponsor's protocol ID
Huiwen Zhang-2024-11
Status last verified
Nov 2024
First submitted
18 Nov 2024
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesiology and Anesthesiology Management, run by General Hospital of Ningxia Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Drug dosage of propofol for inducing loss of consciousness in patients (time frame: through study completion, an average of six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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