Gastroscopy diagnosis and treatment
Conditions
Interventions
R group:Remazolam tosylate
Sponsors
The Fifth People's Hospital of Jinan
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-65 years, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) It is estimated that the gastroscopy operation time will not exceed 30 minutes; 4) ASA score is I or II; 5) 18 kg/m2 < BMI < 30kg/m2; 6) Clearly understand, participate in the research voluntarily, and sign an informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients with mental disorders, obvious memory impairment, and neurological dysfunction; 2) Complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic muscle dissection, etc.) are required; 3) Patients who intend to undergo tracheal intubation; 4) Suspected patients with gastroduodenal outflow tract obstruction accompanied by content retention; 5) Patients suspected of having upper gastrointestinal bleeding; 6) Acute heart failure; unstable angina; myocardial infarction occurred within 6 months before screening; resting ECG heart rate = 450 ms, female >= 470 ms; 7) Patients who are judged to be difficult to manage the respiratory tract (modified Markov score is IV); 8) Suffer from severe respiratory diseases (obstructive sleep apnea syndrome, mouth opening disorder, restricted neck or jaw movement, morbid obesity, acute respiratory infection, acute exacerbation of chronic obstructive pulmonary disease, uncontrolled asthma, etc.) patient; 9) Anemia or thrombocytopenia, PLT = 2.5*ULN, TBIL >= 1.5*ULN; 11) Abnormal renal function, blood creatinine >= 1.5*ULN; 12) Have a history of drug abuse and/or alcohol abuse within 2 years before the beginning of the screening period, alcoholism means drinking more than 2 units of alcohol per day on average (1 unit = 360 mL of beer or 45 mL of 40% alcoholic liquor or 150 mL of wine); 13) Hypertension patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs (sitting systolic blood pressure >= 160 mmHg in the screening period, and/or diastolic blood pressure >= 100 mmHg in the screening period); 14) Sitting systolic blood pressure <= 90 mmHg during the screening period; 15) Women who are pregnant or breastfeeding; 16) Those who are allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine, flumazenil and other drugs and their drug components; 17) Participated in drug clinical trials as subjects in the past 3 months; 18) The investigator believes that it is inappropriate for patients to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurobehavioral cognitive status check; | — |
Secondary
| Measure | Time frame |
|---|---|
| Calm recovery time;Incidence of sedative hypotension;Incidence of respiratory depression;Sedation success rate;Sedation induction time;Discharge time; | — |
Countries
China
Contacts
Public ContactZhaoyu Shi
The Fifth People's Hospital of Jinan
Outcome results
None listed