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

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

This study will test whether conscious sedation or intravenous (IV) general anesthesia causes fewer heart-related problems in frail patients over 65 having digestive endoscopy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 226 (estimated)
• Ages: 65 Years to 100 Years
• Sex: All
• Sponsor: Beijing Friendship Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06192082 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are frail adults older than 65 years (FRAIL score ≥3) with ASA class II–III and BMI 18–28 who are scheduled for digestive endoscopy outside an operating room and can give informed consent.

Not a fit: Patients with recent myocardial infarction, unstable cardiac disease, severe arrhythmias, severe respiratory disease, or allergies/contraindications to the study drugs are excluded and unlikely to benefit from the trial findings.

Why it matters

Potential benefit: If successful, the results could help lower the rate of heart-related complications and improve procedural safety for frail elderly patients undergoing endoscopy.

How similar studies have performed: Midazolam-based conscious sedation and propofol-based IV anesthesia have been compared in other endoscopy populations, but robust data specifically in frail older adults are limited.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Beijing Friendship Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Haijun Hou, MD

Conditions Anesthesia; gastroscopy; frail patients; adverse cardiovascular events