RecruitingNot ApplicableNCT06192082

Adverse Cardiovascular Events During Painless Gastroscopy Diagnosis and Treatment in Elderly Frail Patients

Clinical Study About Impacts of Anesthesia Methods on Adverse Cardiovascular Events During Painless Gastroscopy Diagnosis and Treatment in Elderly Frail Patients

Sponsor

Beijing Friendship Hospital

Enrollment

226 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Anesthesia

Summary

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

Min Age: 65 YearsMax Age: 100 Years

Inclusion Criteria5

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;
FRAIL scale score ≥ 3 points 6 The patient voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria7

Those who are allergic or contraindicated to drugs such as benzodiazepines, opioids, propofol, and their drug components;
\. Acute heart failure; Unstable angina pectoris; Myocardial infarction occurred within 6 months prior to screening; Resting electrocardiogram heart rate<50 beats/minute; Third degree atrioventricular transmission delay; Severe arrhythmia; Moderate to severe heart valve disease;
\. Patients with severe respiratory diseases (acute respiratory infections, acute exacerbations of chronic obstructive pulmonary disease, uncontrolled asthma, etc.);
\. Patients who have not received formal antihypertensive treatment or have poor blood pressure control;
\. Patients with traumatic brain injury, possible presence of intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents, and central nervous system diseases;
\. Individuals with mental system diseases (schizophrenia, mania, bipolar disorder, mental disorder, etc.), long-term history of taking psychotropic drugs, and cognitive impairment;
\. Other situations that have been determined by the researcher to be unsuitable for inclusion.

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Interventions

PROCEDUREThe conscious sedation group

The 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;

PROCEDUREIntravenous general anesthesia group

Intravenous 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.