Conscious sedation versus IV general anesthesia for painless gastroscopy in frail older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Frail patients aged over 65 (ASA II–III, BMI 18–28) undergoing digestive endoscopy outside the operating room will be assigned to one of two anesthesia approaches. Both groups receive preoperative labs and routine monitoring (ECG, NIBP, SpO2) with IV access and fluid replacement; the conscious sedation arm uses sufentanil plus midazolam while the IV general anesthesia arm uses sufentanil plus propofol. Anesthesia depth is monitored using the MOAA/S score and additional sedative boluses are given as needed during the procedure. The primary focus is comparing the incidence of adverse cardiovascular events during diagnosis and treatment procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age greater than 65 years old, regardless of gender
2. ASA is classified as Class II and III;
3. BMI 18-28 kg/m2;
4. Patients undergoing examination or treatment outside the operating room;
5. FRAIL scale score ≥ 3 points 6 The patient voluntarily participated in this study and signed an informed consent form.

Exclusion Criteria:

1 Those who are allergic or contraindicated to drugs such as benzodiazepines, opioids, propofol, and their drug components;

2\. 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;

3\. Patients with severe respiratory diseases (acute respiratory infections, acute exacerbations of chronic obstructive pulmonary disease, uncontrolled asthma, etc.);

4\. Patients who have not received formal antihypertensive treatment or have poor blood pressure control;

5\. Patients with traumatic brain injury, possible presence of intracranial hypertension, cerebral aneurysms, history of cerebrovascular accidents, and central nervous system diseases;

6\. Individuals with mental system diseases (schizophrenia, mania, bipolar disorder, mental disorder, etc.), long-term history of taking psychotropic drugs, and cognitive impairment;

7\. Other situations that have been determined by the researcher to be unsuitable for inclusion.

Where it's running

• Beijing Friendship Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Haijun Hou, MD
• Email: 77790690@qq.com
• Phone: +8618612568228

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.