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

Anesthesia Clinical Trial

— frail  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06192082
• Other study ID #: frail patients
• Status: Completed
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: February 12, 2024

Study information

• Verified date: November 2023
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 12, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

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;
• 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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)