Sedation Level on Machine Learning With Electroencephalogram in Painless Gastroenteroscopy Patients

NCT05545397 | Unknown FDA Drug FDA Device

• 1 other identifier: Huiwen Zhang
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastritis

Keywords

Deep Sedation; Machine learning; EEG characheristics;; Painless gastroscopy

Outcome Measures

Primary Outcomes (2)

• Electroencephalogram features

  Time feature;frequency feature;Entropy

  during gastroenteroscopy procedure

• Propofol dosage

  from awake to sedation in painless gastroenteroscopy

  during gastroenteroscopy procedure

Secondary Outcomes (8)

• physiological parameter(blood pressure )

  during gastroenteroscopy procedure

• physiological parameter(heart rate )

  during gastroenteroscopy procedure

• physiological parameter(oxygen saturation )

  during gastroenteroscopy procedure

• time parameter （Arousal times）

  during endoscopy

• success rate of once endoscopy

  during endoscopy

Study Arms (1)

The propofol group

Patients undergoing painless gastroenteroscopy under general anesthesia

Drug: Propofol; Device: EEG montior

Interventions

Propofol DRUG

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

The propofol group

EEG montior DEVICE

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

The propofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Painless gastroenteroscopy patients
• ASA classification is Ⅰ-Ⅱ
• Patients who are willing to cooperate
• No schizophrenia,epilepsy and other neurological diseases

You may not qualify if:

• allergic to propofol
• Patients who are unwilling to cooperate
• Patients with psychiatric disorders
• Patients using sedative drugs for a long time
• Patients with neuropsychiatric disorders
• Patients with severe heart, liver, kidney and respiratory diseases

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

Ningxia Medical University Cardiovascular and Cerebrovascular Disease Hospital

Yinchuan, The Ningxia Hui Autonomous Region, 750021, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Eeg characteristics at waking time, EEG characteristics at sedation time, induced dose of propofol, and each additional dose of propofol

MeSH Terms

Conditions

Gastritis

Interventions

Propofol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Huiwen Zhang

CONTACT

18709500998; zhanghuiwen1128@163.com

Zhenghong Zhao

CONTACT

13519576995; 592068802@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 19, 2022
• Study Start: September 15, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Locations

CN (1)