Impact of anesthesia methods on adverse cardiovascular events during painless gastroscopy in frail older patients: study protocol for a prospective controlled trial.
Xuming Liu, Haijun Hou
https://pubmed.ncbi.nlm.nih.gov/41868202Actively Recruiting
Phase Not Applicable
Age: 65Years - 100Years
All Genders
ID06192082
Clinical Study on Effects of Anesthesia Methods on Cardiovascular Events During Painless Gastroscopy in Elderly Frail Patients
Led by Beijing Friendship Hospital · Updated on 2026-02-12
226
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare how conscious sedation and intravenous general anesthesia affect cardiovascular events in elderly frail patients undergoing digestive endoscopy for diagnosis and treatment. The study focuses on patients aged 65 to 100 years who are considered frail and need this procedure outside of an operating room setting. It seeks to understand which anesthesia method might be safer or cause fewer heart-related problems during these procedures. Participants are randomly assigned to one of two groups. The conscious sedation group receives sufentanil and midazolam before the procedure, with sedation levels monitored and adjusted as needed during the endoscopy. The intravenous general anesthesia group receives sufentanil and propofol, with doses tailored based on the patient's sleep depth and tolerance to the procedure. Both groups undergo continuous monitoring of heart rate, blood pressure, oxygen levels, and electrocardiograms during and shortly after the procedure. During the study, patients will have regular measurements of vital signs and heart monitoring, with any abnormalities recorded until the endoscope is removed. Researchers will collect feedback on satisfaction from patients, gastroenterologists, and anesthesiologists. Follow-up calls within three days will check for any side effects like dizziness, headache, or nausea. The main outcome measured is the occurrence of adverse cardiovascular events during the procedure and recovery period, with additional assessments of other side effects, pain scores, and satisfaction levels.
CONDITIONS
Brief Title
Adverse Cardiovascular Events During Painless Gastroscopy Diagnosis and Treatment in Elderly Frail Patients
Who Can Participate
Age: 65Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age greater than 65 years old
- ASA classified as Class II or III
- Body Mass Index (BMI) between 18 and 28 kg/m2
- Undergoing examination or treatment outside the operating room
- FRAIL scale score of 3 or higher
- Voluntary participation with signed informed consent
You will not qualify if you...
- Allergy or contraindication to benzodiazepines, opioids, propofol, or components
- Acute heart failure, unstable angina, or recent myocardial infarction within 6 months
- Resting heart rate less than 50 beats per minute or third degree atrioventricular block
- Severe arrhythmia or moderate to severe heart valve disease
- Severe respiratory diseases such as acute infections or uncontrolled asthma
- Uncontrolled blood pressure or no formal antihypertensive treatment
- Traumatic brain injury, intracranial hypertension, cerebral aneurysms, cerebrovascular history, or central nervous system disorders
- Mental illnesses like schizophrenia, bipolar disorder, or cognitive impairment
- Long-term use of psychotropic drugs
- Any other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 hours (examination and recovery room time)
Participants receive either conscious sedation or intravenous general anesthesia during painless gastroscopy. The procedure includes preoperative evaluations, administration of anesthesia, insertion of a digestive endoscope, monitoring of vital signs during the examination, and recording of any cardiovascular or other adverse events.
1 procedure visit (in-person)
Follow-up
Duration - 3 days
Participants are followed up by phone within three days after the procedure to assess any adverse events such as dizziness, headache, palpitations, wheezing, mobility issues, nausea, and vomiting.
1 follow-up phone call
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
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Research Team
H
Haijun Hou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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