Gastric Cancer, Hypoxia, Propofol Adverse Reaction, Sedation Complication
Conditions
Keywords
Hypoxia, Efficacy and Safety, Gastroscope, Remimazolam, Propofol
Brief summary
Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
Interventions
Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
DRUGPropofol
Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high.
Sponsors
Shanghai East Hospital
Affiliated Hospital of Jiaxing University
The Second Affifiliated Hospital of Jiaxing University
The First Affiliated Hospital of Nanchang University
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
\- 1)18≤age≤60 years old, no gender limit; 2) Patients receiving routine gastroscopy diagnosis and treatment; 3) ASA score is I or II; 4) 18 kg/m2\<BMI\<28kg/m2； 5) It is estimated that the operation time of gastroscope will not exceed 30 minutes; 6) Clearly understand, voluntarily participate in the research, and be signed and informed consent.
Exclusion criteria
1. Need to perform complicated endoscopic diagnosis and treatment techniques (such as cholangiopancreatography Surgery, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosa Stripping, oral endoscopic muscle dissection, etc.); 2. Patients who intend to undergo tracheal intubation; 3. It is judged to be difficult to manage the respiratory tract (modified Mallampati score is IV)patient; 4. Anemia or thrombocytopenia,( Hb\<90g/L, PLT\<80×109/L); 5. Diagnosed lung diseases (asthma, bronchitis, COPD, Pulmonary bullae,pulmonary embolism, pulmonary edema, lung cancer); 6. Liver and kidney disease;( AST and/or ALT≥2.5×ULN,TBIL≥1.5×ULN, blood creatinine is greater than the upper limit of normal); 7. There is a history of drug and/or alcohol abuse within 2 years before the beginning of the screening period.The average daily alcohol consumption exceeds 2 units of alcohol (1 unit = 360 mL beer Liquor or 45 mL liquor with 40% alcohol content or 150 mL grapes liqueur); 8. Hypertensive patients whose blood pressure has not been satisfactorily controlled by antihypertensive drugs(Sitting systolic blood pressure ≥160 mmHg during screening period, and/or diastolic pressure during screening period Pressure ≥100 mmHg); 9. Sitting systolic blood pressure ≤90 mmHg during the screening period; 10. Women who are pregnant or breastfeeding; 11. Benzodiazepines, opioids, propofol, lidoca Those who are allergic or contraindicated due to their drug components; 12. Participated in other drug clinical trials as subjects in the past 3 months; 13. The investigator believes that it is not appropriate to participate in this trial; 14. A well-diagnosed heart disease (heart failure, angina pectoris, myocardial infarction, heart rhythmabnormalities etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | 1\) Complete the entire process of gastroscopy; 2) No sedative remedy is given; 3) After the initial dose of the test drug is administered, additional administration ≤ 2 times within any 5-minute period; 4) The initial dose of propofol After the end, within any 5-minute period of additional administration ≤ 2 times, it is recorded as propofol (control group) successfully sedated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedation recovery time | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | recovery time |
| Incidence of drug injection pain | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | drug injection pain |
| Doctor satisfaction and patient satisfaction | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | There is a scale from 1 to 10. Endoscopists and patients will score their satisfaction with the scale ,with 1-3 (dissatisfied),4-6 (satisfied) and 7-10 (very satisfied) after gastroscopy. |
| Sedation induction time | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | induction time |
| The incidence of hypoxia during sedation | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | (75% ≤ SpO2 \< 90% for \<60 s)；(SpO2 \< 75% for any duration or 75% \< SpO2 \< 90% for \>/=60 s) |
| Other adverse events assessed by the World SIVA adverse sedation event reporting tool | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events. |
| The time it takes for the patient to wake up and leave the hospital if the Sedation/Anaesthesia Discharge Rating Scale score exceeds 9 points; | Patients will be followed for the duration of hospital stay, an expected average of 2 hours | Sedation/Anaesthesia Discharge Rating Scale |
Countries
China
Contacts
Primary ContactDiansan Su, Dr.
Backup ContactHuichen zhu, M.S.
Outcome results
None listed