Individuals undergoing digestive endoscopy
Conditions
Interventions
Group A:Oxeladin 0.02 mg/kg (intravenous bolus) ? Dexmedetomidine 0.25 µg/kg (intravenous bolus) ? Cicloprofen 0.25 mg/kg (intravenous bolus)
intraoperative supplemental Cicloprofen 0.2 mg/kg (single dose)
Group B:Oxeladin 0.02 mg/kg (intravenous bolus) ? Cicloprofen 0.4 mg/kg (intravenous bolus)
Group C:Alfentanil 7 µg/kg (intravenous bolus) ? Cicloprofen 0.4 mg/kg (intravenous bolus)
Sponsors
Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients (aged 18-70) who are scheduled to undergo gastroscopy or colonoscopy: This population is the main clinical group for gastroscopy and colonoscopy anesthesia, and the research results have direct clinical translational value. 2. ASA Grade I-III: It covers the vast majority of patients without severe underlying diseases or with stable control of underlying diseases in clinical practice, ensuring that the research results are applicable to a wide range of clinical scenarios. 3. BMI 18.5-29.9kg/m^2 : Obese patients (BMI>=30kg/m^2) are excluded, as this population may have problems such as airway stenosis and decreased respiratory reserve, which significantly increase the confuming risk of hypoxia. At the same time, including BMI in the criteria can ensure the homogeneity of baseline respiratory function in the subjects.
Exclusion criteria
Exclusion criteria: 1. For those allergic to drugs: Avoid safety risks and data interference caused by allergic reactions; 2. Patients with difficult airways, uncontrolled severe respiratory diseases, and OSA: The baseline respiratory risk of such patients is extremely high, and it is difficult to distinguish whether hypoxia is caused by the study protocol or underlying diseases, which will seriously affect the outcome judgment. 3. Severe liver and kidney dysfunction and severe cardiovascular diseases: Drugs such as oxelidine and dexmedetomidine need to be metabolized by the liver and kidneys and have certain impacts on the cardiovascular system. The safety risk of medication for such patients is high, and it may affect pharmacokinetics and interfere with research results. 4. Long-term use of opioids and the use of analgesics within 48 hours before surgery: This may lead to opioid tolerance, affecting the analgesic effects of oxelidin and afentanil, and thereby interfering with the effectiveness evaluation of anesthesia regimens. 5. Pregnant or lactating women: Avoid studying the potential risks that drugs may pose to the fetus or infant; 6. For those with mental disorders who are unable to cooperate: Ensure that the subjects can cooperate to complete the informed consent, examination and follow-up processes, and guarantee the integrity of the data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intraoperative hypoxia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of subclinical respiratory depression and severe hypoxia during examination;Incidence of bradycardia, tachycardia, hypotension, and hypertension;Incidence of patient movement;Post-procedure recovery time (awakening time, discharge time);Patient satisfaction with gastrointestinal endoscopy anesthesia and gastroenterologist satisfaction with anesthesia;Incidence of post-procedural nausea, vomiting, and other adverse events; | — |
Countries
China
Contacts
Public ContactYe Zhi
Xiangya Hospital, Central South University
Outcome results
None listed