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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: The conscious sedation group; Procedure: Intravenous general anesthesia group

Detailed Description

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.

Both sets of anesthesia plans completed preoperative evaluations, including blood count, coagulation function, liver and kidney function, and cardiopulmonary function. Routine monitoring of electrocardiograms (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), open veins, and administration of a balance solution of 3-5ml/kg. h. 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; 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. All anesthetics should be discontinued before the end of the surgery. Since the examination, blood pressure should be measured every 2 minutes, while HR, SpO2, and RR should be recorded to observe if there are any abnormalities in the electrocardiogram. If there are any abnormalities, please explain until the endoscope is removed from the dental pad. Record the satisfaction of gastroenterologists, anesthesiologists, and patients after surgery. Follow up patients by phone within three days after surgery to determine the incidence of adverse events (dizziness, headache, palpitations, wheezing, mobility, nausea and vomiting).

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haijun Hou, MD; Phone Number: +8618612568228; Email: 77790690@qq.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Haijun Hou; Phone Number: +8618612568228; Email: 77790690@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The conscious sedation group; conscious sedation	Procedure: The 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; Other Names: Group A
Active Comparator: Intravenous general anesthesia group; Intravenous general anesthesia	Procedure: Intravenous 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.; Other Names: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	during the examination and recovery room time(up to 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	during the examination and recovery room time(up to 2 hours)
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.	during the examination and recovery room time(up to 2 hours)
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.	during the examination and recovery room time(up to 2 hours)

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Study Chair: Haijun Hou, MD, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): February 12, 2026
• Study Completion (Estimated): February 12, 2026

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: gastroscopy; adverse cardiovascular events; frail patients
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: frail patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No