Gastrointestinal disease
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Xinxiang Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects receiving painless gastrointestinal endoscopy; 2. Male or female, ASA classification I-III, aged 18to 80 years; 3. Body mass index (BMI) >=18 and =10 and =93%; SBP>=90mmHg; DBP>=55mmHg; Heart rate should be >=50 and <=100 breaths/min; 5. Able to understand the procedures and methods of this research, willing to sign an informed consent form and strictly abide by the clinical research protocol to complete this research.
Exclusion criteria
Exclusion criteria: 1. Those with contraindications to deep sedation/general anesthesia or those who have had a history of sedation/anesthesia accident in the past; 2. Those who are known to be allergic to eggs, soy products, opioids and their remedies, propofol, etc.; 3. Patients who have been intubated and/or mechanically ventilated before diagnosis and treatment; 4. History or evidence of the following increased sedation/anesthesia risk: Cardiovascular history: uncontrolled hypertension, aneurysm, severe arrhythmia, heart failure, Adams-stokes syndrome, New York Heart Association ( NYHA) cardiac function class >= III, severe superior vena cava occlusion syndrome, pericardial effusion, acute myocardial ischemia, unstable angina pectoris, myocardial infarction within 6 months before screening, tachycardia/tachycardia requiring drug treatment History of chronic obstructive pulmonary disease, II-III degree AV block (excluding patients with pacemaker) or QTcF interval >=450ms; Respiratory history: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, Throat mass, history of (branch) tracheoesophageal fistula or airway tear, severe respiratory infection within the past 2 weeks before screening; neurological and psychiatric history: craniocerebral injury, cerebral aneurysm, cerebrovascular accident history; psychiatric Schizophrenia, mania, long-term use of psychotropic drugs, history of cognitive dysfunction, etc.; gastrointestinal history: gastrointestinal retention, active bleeding, gastroesophageal reflux or obstruction history, etc. may lead to reflux aspiration ; Uncontrolled and clinically significant liver, kidney, blood system, nervous system or metabolic system and other diseases that the investigator judges may not be suitable for participating in the study; a history of alcoholism, which is an average of >2 units of alcohol per day (1 Unit = 360mL beer or 45mL liquor with 40% alcohol content or 150mL wine); 5. Pregnant and lactating women; fertile women or men who are unwilling to use contraception throughout the study period; or subjects (including male subjects) who plan to become pregnant within 3 months after the end of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs during sedation; | — |
Countries
China
Contacts
Public ContactYue Xiuqin
The First Affiliated Hospital of Xinxiang Medical College
Outcome results
None listed