About this trial
This study aims to compare the effects of conscious sedation and intravenous general anesthesia on cardiovascular events in frail patients undergoing digestive endoscopy diagnosis and treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age greater than 65 years old, regardless of gender
ASA is classified as Class II and III;
BMI 18-28 kg/m2;
Patients undergoing examination or treatment outside the operating room;
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
The conscious sedation group
Procedure/SurgeryThe conscious sedation group (Group A) received sufentanil 0.05-0.1 5 minutes before examination μ G/kg, administration time 30 seconds, 1-2 mg of midazolam administered 2 minutes before examination; Evaluate the patient's MOAA/S score, insert a digestive endoscope at 2-3 minutes, and add 1-2mg of midazolam if the patient is unable to tolerate coughing or movement during the examination. Reevaluate the MOAA/S score, and continue the operation after 2-3 minutes;
Intravenous general anesthesia group
Procedure/SurgeryIntravenous general anesthesia group (Group B): sufentanil 0.05-0.1 μ G/kg, administration time 30 seconds, 1mg/kg of propofol administered 2 minutes before examination. Depending on the patient's sleep status, 10mg of propofol can be administered every 30 seconds; Evaluate the patient's MOAA/S score. At 0-1 points, a digestive endoscope is inserted. If there is coughing or physical activity during the examination that the patient cannot tolerate, propofol 10-20mg can be administered multiple times. Evaluate the MOAA/S score again, and continue the operation after 0-1 points.
Treatment groups
Trial outcomes
Primary outcomes
Adverse cardiovascular events
The occurrence rate of heart rate abnormal events (defined as heart rate abnormal events with a baseline fluctuation of ± 30%);The incidence of blood pressure fluctuation events (defined as blood pressure fluctuation events with a baseline blood pressure fluctuation of ± 30%);The incidence of angina, myocardial infarction, cardiac arrest, acute heart
Secondary outcomes
The incidence of other adverse events
The incidence of other adverse events (SPO2\<90%, apnea, physical activity, pain, coughing, aspiration, muscle tremor, nausea and vomiting, difficulty breathing, etc.)
VAS score
VAS score, also known as visual simulation score, can be divided into 10 equal parts, with 0 being no pain and 10 being the most painful.
Satisfaction score
Satisfaction of patients, endoscopists, and anesthesiologists.The can be divided into 10 equal parts, with 0 being no satisfaction and 10 being the most satisfaction.
Sponsors and contacts
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