AnesthesiafrailNCT06192082
Adverse Cardiovascular Events During Painless Gastroscopy Diagnosis and Treatment in Elderly Frail Patients
A study testing The conscious sedation group and Intravenous general anesthesia group in people with Anesthesia, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- The conscious sedation group and Intravenous general anesthesia group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Haijun Hou, +8618612568228, 77790690@qq.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Anesthesia
- Being tested
- The conscious sedation group, Intravenous general anesthesia group
- Keywords
- gastroscopy, frail patients, adverse cardiovascular events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The conscious sedation groupProcedure or surgery
Also called Group A
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 groupProcedure or surgery
Also called Group B
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.
| Study group | Role | What they receive |
|---|---|---|
| The conscious sedation group | Experimental | conscious sedation Receives: Procedure: The conscious sedation group |
| Intravenous general anesthesia group | Active comparator | Intravenous general anesthesia Receives: Procedure: Intravenous general anesthesia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the examination and recovery room time(up to 2 hours)
Secondary outcomes (3)
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.)
Measured: 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.
Measured: 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.
Measured: during the examination and recovery room time(up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2024
- Primary completion12 Feb 2026 (estimated)
- Study completion12 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192082
- Sponsor's protocol ID
- frail patients
- Acronym
- frail
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41868202
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study About Impacts of Anesthesia Methods on Adverse Cardiovascular Events During Painless Gastroscopy Diagnosis and Treatment in Elderly Frail Patients
- ClinicalTrials.gov ID
- NCT06192082
- Acronym / sponsor ID
- frail / frail patients
- Conditions
- Anesthesia
- Keywords
- gastroscopy, frail patients, adverse cardiovascular events
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 12 Feb 2026 (estimated)
- Study completion
- 12 Feb 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The conscious sedation group | Experimental | Procedure: The conscious sedation groupconscious sedation |
| Intravenous general anesthesia group | Active comparator | Procedure: Intravenous general anesthesia groupIntravenous general anesthesia |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The conscious sedation groupAlso: Group AThe 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; | Procedure or surgery | The conscious sedation group |
| Intravenous general anesthesia groupAlso: Group BIntravenous 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. | Procedure or surgery | Intravenous general anesthesia group |
Primary outcome
Adverse cardiovascular events
Time frame: during the examination and recovery room time(up to 2 hours)
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
3 secondary outcomes
The incidence of other adverse events
Time frame: during the examination and recovery room time(up to 2 hours)
VAS score
Time frame: during the examination and recovery room time(up to 2 hours)
Satisfaction score
Time frame: during the examination and recovery room time(up to 2 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 41868202Liu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The conscious sedation group and Intravenous general anesthesia group in people with Anesthesia, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haijun Hou, MD (+8618612568228, 77790690@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse cardiovascular events (time frame: during the examination and recovery room time(up to 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06192082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.