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.
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
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.
- Conditions
- Anesthesiology, Anesthesiology Management
- 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.
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)
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
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
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.
- First posted25 Nov 2024
- Study start20 Nov 2024
- Primary completion30 Mar 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning-Based Model for Individualized Drug Dose Prediction for Propofol-Induced Loss of Consciousness in Patients
- ClinicalTrials.gov ID
- NCT06703879
- Acronym / sponsor ID
- Huiwen Zhang-2024-11
- Conditions
- Anesthesiology, Anesthesiology Management
- Keywords
- machine learning, propofol-induced loss of consciousness in patients, predict model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients requiring elective surgery or outpatient painless endoscopic surgery; Induction of anesthesia with propofol
Key inclusion criteria (1 listed)
- Inpatients requiring elective surgery or outpatient painless endoscopic surgery; Induction of anesthesia with propofol; Age≥18 years old; ASA classifications I-III
Key exclusion criteria (1 listed)
- Propofol allergy; Contraindication to anesthesia; Declined to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia induction with propofolAlso: Induction of anesthesia by intravenous infusion of propofolEstablishment 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 | Drug | – |
Primary outcome
Drug dosage of propofol for inducing loss of consciousness in patients
Time frame: through study completion, an average of six months
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.
3 secondary outcomes
Relevant factors that can influence the intravenous dose of propofol
Time frame: through study completion, an average of six months
Patient's peri-anesthetic vital signs
Time frame: through study completion, an average of six months
Characteristics of the patient's perianesthesia electroencephalogram
Time frame: through study completion, an average of six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.