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

NCT06192082 | Recruiting DMC

• 1 other identifier: frail patients
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Keywords

gastroscopy; frail patients; adverse cardiovascular events

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The incidence of other adverse events

  during the examination and recovery room time(up to 2 hours)

• VAS score

  during the examination and recovery room time(up to 2 hours)

• Satisfaction score

  during the examination and recovery room time(up to 2 hours)

Study Arms (2)

The conscious sedation group

EXPERIMENTAL

conscious sedation

Procedure: The conscious sedation group

Intravenous general anesthesia group

ACTIVE COMPARATOR

Intravenous general anesthesia

Procedure: Intravenous general anesthesia group

Interventions

Intravenous general anesthesia group PROCEDURE

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.

Also known as: Group B

Intravenous general anesthesia group

The conscious sedation group PROCEDURE

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;

Also known as: Group A

The conscious sedation group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• Liu X, Hou H. Impact of anesthesia methods on adverse cardiovascular events during painless gastroscopy in frail older patients: study protocol for a prospective controlled trial. Front Med (Lausanne). 2026 Mar 5;13:1784922. doi: 10.3389/fmed.2026.1784922. eCollection 2026.

  PMID: 41868202 DERIVED

Central Study Contacts

Haijun Hou, MD

CONTACT

+8618612568228; 77790690@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: On the premise of ensuring clinical work and safety, in order to objectively evaluate the research results, the single blind method is reasonably used in this project. Patients are unaware of the anesthesia plan, and preoperative data collection and implementation of the anesthesia plan are carried out by experienced anesthesiologists who have undergone detailed training. Postoperative PACU clinical data and postoperative follow-up were followed up by another anesthesiologist who was unaware of the trial group over the phone.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using a stratified randomization method, the candidate subjects were divided into two groups: the conscious sedation group (Group A); Intravenous general anesthesia group (Group B); There are 113 cases in each group, with a total of 226 cases in both groups. The computer generated random group numbers will be printed and placed in a separate sealed envelope. When accepting subjects who meet the inclusion criteria, the anesthesiologist will assign the newly recruited subjects to the corresponding groups based on the number in the envelope, and the anesthesiologist will be responsible for recording the physiological characteristics of the patients. Another anesthesiologist followed up the patient after the surgery. Both the follow-up doctor and the patient are unaware of the treatment plan. In emergency situations, anesthesiologists can change the anesthesia method to ensure clinical safety and truthfully record it.

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 5, 2024
• Study Start: January 1, 2024
• Primary Completion: February 12, 2026
• Study Completion: February 12, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)