Sedation Level on Machine Learning With Electroencephalogram in Painless Gastroenteroscopy Patients

Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545397
• Other study ID #: Huiwen Zhang
• Status: Recruiting
• Start date: September 15, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: General Hospital of Ningxia Medical University
• Contact: Huiwen Zhang
• Phone: 18709500998
• Email: zhanghuiwen1128[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Painless gastroenteroscopy patients

2. ASA classification is ?-?

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

Related Conditions & MeSH terms

• Gastritis

Intervention

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

Locations

Country	Name	City	State
China	Ningxia Medical University Cardiovascular and Cerebrovascular Disease Hospital	Yinchuan	The Ningxia Hui Autonomous Region

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electroencephalogram features	Time feature;frequency feature;Entropy	during gastroenteroscopy procedure
Primary	Propofol dosage	from awake to sedation in painless gastroenteroscopy	during gastroenteroscopy procedure
Secondary	physiological parameter(blood pressure )	from awake to sedation in painless gastroenteroscopy with ECG monitor	during gastroenteroscopy procedure
Secondary	physiological parameter(heart rate )	from awake to sedation in painless gastroenteroscopy with ECG monitor	during gastroenteroscopy procedure
Secondary	physiological parameter(oxygen saturation )	from awake to sedation in painless gastroenteroscopy with ECG monitor	during gastroenteroscopy procedure
Secondary	time parameter (Arousal times)	with monitor and Anesthesiologist's record	during endoscopy
Secondary	success rate of once endoscopy	with monitor and Anesthesiologist's record	during endoscopy
Secondary	Incidence of hypoxemia	with monitor and Anesthesiologist's record	during endoscopy
Secondary	Endoscopist satisfaction by questionnaire	with monitor and Anesthesiologist's record	during endoscopy
Secondary	vasoactive drugs	with monitor and Anesthesiologist's record	during endoscopy