Sedation Level on Machine Learning With Electroencephalogram in Painless Gastroenteroscopy Patients

Sedation Level Estimation Based on Machine Learning of Quantitative Occipital Electroencephalogram Features in Gastroenteroscopy Patients

Painless endoscopy technology can make patients comfortable under anesthesia, but because of the painless inside.The diagnosis and treatment time of endoscopic examination is short, and the transport is fast. Anesthesia related wind such as deep breathing depression and hypoxemia will occurRisks.Eeg depth monitoring can assist anesthesiologists to evaluate the depth of anesthesia and reduce the risk. Artificial intelligence is adopted.There are few reports on the evaluation of anesthesia depth and drug dosage by electroencephalogram (EEG) monitoring in outpatient patients with painless gastroenteroscopy.

Study Overview

• Status: Recruiting
• Conditions: Gastritis
• Intervention / Treatment: Drug: Propofol; Device: EEG montior

Detailed Description

1.examination, and establish brainClassification model of electrogram and sedation depth;2. The EEG characteristics, basic information and propofol were administered to all patients.The dose model of propofol painless gastroenteroscopy was established by machine learning to guide anesthesia Drug use;3. Evaluate the time and space complexity of the model, build the model, and assist the anesthesiologist to individualize the patient Chemical, safe and comfortable management.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Huiwen Zhang; Phone Number: 18709500998; Email: zhanghuiwen1128@163.com
• Study Contact Backup: Name: Zhenghong Zhao; Phone Number: 13519576995; Email: 592068802@qq.com

Study Locations

• China
  • The Ningxia Hui Autonomous Region
    • Yinchuan, The Ningxia Hui Autonomous Region, China, 750021
      • Recruiting
      • Ningxia Medical University Cardiovascular and Cerebrovascular Disease Hospital
      • Contact: Zhang Huiwen; Phone Number: 18709500998; Email: zhanghuiwen1128@163.com
      • Contact: Ma Hanxiang; Phone Number: 13519591 598

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who were eligible for this study were monitored by EEG, and propol was pumped at a rate of 600ml/h，MOAA/S was used to evaluate the depth of anesthesia. EEG was labeled, and the amount of propofol was recorded.The MATLAB software was used to analyze the EEG features, establish the classifier and establish the painless gastroenteroscopy of propofol induction dosage prediction model.

Description

Inclusion Criteria:

1. Painless gastroenteroscopy patients
2. ASA classification is Ⅰ-Ⅱ
3. Patients who are willing to cooperate
4. No schizophrenia,epilepsy and other neurological diseases

Exclusion Criteria:

1. allergic to propofol
2. Patients who are unwilling to cooperate
3. Patients with psychiatric disorders
4. Patients using sedative drugs for a long time
5. Patients with neuropsychiatric disorders
6. Patients with severe heart, liver, kidney and respiratory diseases

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The propofol group; Patients undergoing painless gastroenteroscopy under general anesthesia	Drug: Propofol; And pump propofol at a rate of 600ml/h. The degree of sedation was assessed by the MOAA/S scale until the depth sadation of the patient during the monitor of EEG; Device: EEG montior; And pump propofol at a rate of 600ml/h. The degree of sedation was assessed by the MOAA/S scale until the depth sadation of the patient during the monitor of EEG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalogram features	Time feature;frequency feature;Entropy	during gastroenteroscopy procedure
Propofol dosage	from awake to sedation in painless gastroenteroscopy	during gastroenteroscopy procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physiological parameter(blood pressure )	from awake to sedation in painless gastroenteroscopy with ECG monitor	during gastroenteroscopy procedure
physiological parameter(heart rate )	from awake to sedation in painless gastroenteroscopy with ECG monitor	during gastroenteroscopy procedure
physiological parameter(oxygen saturation )	from awake to sedation in painless gastroenteroscopy with ECG monitor	during gastroenteroscopy procedure
time parameter （Arousal times）	with monitor and Anesthesiologist's record	during endoscopy
success rate of once endoscopy	with monitor and Anesthesiologist's record	during endoscopy
Incidence of hypoxemia	with monitor and Anesthesiologist's record	during endoscopy
Endoscopist satisfaction by questionnaire	with monitor and Anesthesiologist's record	during endoscopy
vasoactive drugs	with monitor and Anesthesiologist's record	during endoscopy

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2022
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 18, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Deep Sedation; Machine learning; EEG characheristics;; Painless gastroscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: Huiwen Zhang

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No