Pain ManagementNCT06712264
Construction and Effectiveness Evaluation of Painless Digestive Endoscopy Mode Led by Anesthesia Nurses Under the Guidance of Anesthesiologists
An observational study of Pain Management and Endoscopy, Gastrointestinal, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The purpose is to verify the effectiveness and safety of the painless digestive endoscopy mode led by anesthesia nurses under the guidance of anesthesiologists. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pain Management, Endoscopy, Gastrointestinal
- How many people
- 18,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population undergoing gastrointestinal endoscopy examination at Qingdao University Affiliated Hospital from December 2024 to February 2025.
Who may be able to join
- Age ≥ 16 years old,
- no oral intake before surgery: liquid for 2 hours, solid for 6 hours.
Who cannot join
- American Society of Anesthesiology (ASA) classification greater than III,
- sleep apnea,
- allergies to soybeans, eggs, or peanuts,
- pregnancy,
- previous anesthesia related complications,,
- potential difficult ventilation,
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- acute gastrointestinal bleeding,
- sub intestinal obstruction,
- severe chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose is to verify the effectiveness and safety of the painless digestive endoscopy mode led by anesthesia nurses under the guidance of anesthesiologists.
Read the detailed description
- Research background Painless diagnosis and treatment, as a treatment method to alleviate patients' pain and avoid psychological and physiological adverse reactions caused by pain, has gradually expanded its application scope. With the increasing demand for comfortable healthcare in society, how to efficiently and safely implement painless diagnosis and treatment has become a focus of clinical attention. Gastrointestinal endoscopy has received increasing attention and is the gold standard for gastrointestinal examinations. WHO recommends that people over 20 years old undergo gastrointestinal endoscopy. Statistics show that in 2021, the number of gastrointestinal endoscopy examinations in China was 38 million, and it is estimated that the number of people who need to undergo gastrointestinal endoscopy examinations in China will exceed 100 million by 2030. With the improvement of living standards and the deepening of the concept of comfortable medical care, more and more people choose painless gastroscopy. The number of painless gastroscopy in China has skyrocketed since 2010. In 2005, the painless rate was less than 10%, and it gradually increased after 2010. The results of a survey on the implementation status of painless gastroscopy in China published in BJA in 2020 showed that the overall painless rate of gastroscopy in China is around 45%, and there has been great progress in the painless rate as soon as possible. However, there is a big gap between the painless diagnosis and treatment of gastroscopy in China and Europe and America, and the sedation rate of gastroscopy in Europe and America has approached 100%. The main problem causing this situation is the severe shortage of anesthesiologists in China at present. The current number of anesthesiologists in China is 100000, with a shortage of up to 250000 anesthesiologists. The existing number of anesthesiologists is already struggling to cope with the annual surgical workload of nearly 60 million researchers. Long term high workload and high pressure have led to a constant occurrence of overwork and death among anesthesiologists. Anesthesiology is the department with the highest sudden death rate among all clinical departments. In this context, researchers creatively proposed and implemented a painless diagnosis and treatment model led by anesthesia nurses under the guidance of anesthesiologists in 2019, which improved work efficiency and economic resource utilization, saved medical costs, met the people's demand for comfortable diagnosis and treatment, and effectively solved the problem of shortage of anesthesiologists. However, there is still a lack of unified standards for the training, assessment, admission, supervision, and diagnosis and treatment processes of anesthesia nurses involved in the effective operation of this model, and its effectiveness and safety also lack convincing evidence.
- Research objective Verify the effectiveness and safety of the painless digestive endoscopy mode led by anesthesia nurses under the guidance of anesthesiologists.
- Research significance Through this study, we will further standardize the training, assessment, admission, supervision, and diagnosis and treatment processes for anesthesia nurses, and verify the effectiveness and safety of this model through quality evaluation tools and indicators such as doctor-patient satisfaction. This will provide a basis for the further promotion of this model and open up a new path for the effective development of comfortable medical safety.
- Conditions
- Pain Management, Endoscopy, Gastrointestinal
- Keywords
- Painless endoscopy, Anesthesia doctors guide anesthesia nurses, sedation
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed Group | Sedation administered by anesthetic nurses under the guidance of anesthesiologists | |
| Unexposed Group | Sedation administered by anesthesiologists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation related adverse events
During and after the examination process summarized by the adverse event reporting tool, the incidence of adverse events such as hypotension, hypertension, tachycardia, bradycardia, arrhythmia, hypoxemia, apnea, coughing (continuous coughing without wheezing, considered as a single cough), and body movements (non directive limb movements) were recorded. The incidence of adverse events during painless endoscopic diagnosis and treatment by anesthesiologists and anesthesiologists, as well as the number and reasons for anesthesiologists seeking help from anesthesiologists, were also recorded
Measured: During the anesthesia process
Secondary outcomes (1)
Patient satisfaction
Complete a Patient Satisfaction Survey (PSSI) before the patient leaves the hospital, using a 100mm Visual Analog Scale (VAS) (0=completely dissatisfied, 100=completely satisfied).
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Dec 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jixiangyu, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712264
- Sponsor's protocol ID
- QYFYEC2024-234
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Effectiveness Evaluation of Painless Digestive Endoscopy Mode Led by Anesthesia Nurses Under the Guidance of Anesthesiologists
- ClinicalTrials.gov ID
- NCT06712264
- Acronym / sponsor ID
- QYFYEC2024-234
- Conditions
- Pain Management, Endoscopy, Gastrointestinal
- Keywords
- Painless endoscopy, Anesthesia doctors guide anesthesia nurses, sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,000 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 2 Dec 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.
The purpose is to verify the effectiveness and safety of the painless digestive endoscopy mode led by anesthesia nurses under the guidance of anesthesiologists.
Detailed description
- Research background Painless diagnosis and treatment, as a treatment method to alleviate patients' pain and avoid psychological and physiological adverse reactions caused by pain, has gradually expanded its application scope. With the increasing demand for comfortable healthcare in society, how to efficiently and safely implement painless diagnosis and treatment has become a focus of clinical attention. Gastrointestinal endoscopy has received increasing attention and is the gold standard for gastrointestinal examinations. WHO recommends that people over 20 years old undergo gastrointestinal endoscopy. Statistics show that in 2021, the number of gastrointestinal endoscopy examinations in China was 38 million, and it is estimated that the number of people who need to undergo gastrointestinal endoscopy examinations in China will exceed 100 million by 2030. With the improvement of living standards and the deepening of the concept of comfortable medical care, more and more people choose painless gastroscopy. The number of painless gastroscopy in China has skyrocketed since 2010. In 2005, the painless rate was less than 10%, and it gradually increased after 2010. The results of a survey on the implementation status of painless gastroscopy in China published in BJA in 2020 showed that the overall painless rate of gastroscopy in China is around 45%, and there has been great progress in the painless rate as soon as possible. However, there is a big gap between the painless diagnosis and treatment of gastroscopy in China and Europe and America, and the sedation rate of gastroscopy in Europe and America has approached 100%. The main problem causing this situation is the severe shortage of anesthesiologists in China at present. The current number of anesthesiologists in China is 100000, with a shortage of up to 250000 anesthesiologists. The existing number of anesthesiologists is already struggling to cope with the annual surgical workload of nearly 60 million researchers. Long term high workload and high pressure have led to a constant occurrence of overwork and death among anesthesiologists. Anesthesiology is the department with the highest sudden death rate among all clinical departments. In this context, researchers creatively proposed and implemented a painless diagnosis and treatment model led by anesthesia nurses under the guidance of anesthesiologists in 2019, which improved work efficiency and economic resource utilization, saved medical costs, met the people's demand for comfortable diagnosis and treatment, and effectively solved the problem of shortage of anesthesiologists. However, there is still a lack of unified standards for the training, assessment, admission, supervision, and diagnosis and treatment processes of anesthesia nurses involved in the effective operation of this model, and its effectiveness and safety also lack convincing evidence.
- Research objective Verify the effectiveness and safety of the painless digestive endoscopy mode led by anesthesia nurses under the guidance of anesthesiologists.
- Research significance Through this study, we will further standardize the training, assessment, admission, supervision, and diagnosis and treatment processes for anesthesia nurses, and verify the effectiveness and safety of this model through quality evaluation tools and indicators such as doctor-patient satisfaction. This will provide a basis for the further promotion of this model and open up a new path for the effective development of comfortable medical safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Group | – | –Sedation administered by anesthetic nurses under the guidance of anesthesiologists |
| Unexposed Group | – | –Sedation administered by anesthesiologists |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population undergoing gastrointestinal endoscopy examination at Qingdao University Affiliated Hospital from December 2024 to February 2025.
Key inclusion criteria (2 listed)
- Age ≥ 16 years old,
- no oral intake before surgery: liquid for 2 hours, solid for 6 hours.
Key exclusion criteria (9 listed)
- American Society of Anesthesiology (ASA) classification greater than III,
- sleep apnea,
- allergies to soybeans, eggs, or peanuts,
- pregnancy,
- previous anesthesia related complications,,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sedation related adverse events
Time frame: During the anesthesia process
During and after the examination process summarized by the adverse event reporting tool, the incidence of adverse events such as hypotension, hypertension, tachycardia, bradycardia, arrhythmia, hypoxemia, apnea, coughing (continuous coughing without wheezing, considered as a single cough), and body movements (non directive limb movements) were recorded. The incidence of adverse events during painless endoscopic diagnosis and treatment by anesthesiologists and anesthesiologists, as well as the number and reasons for anesthesiologists seeking help from anesthesiologists, were also recorded
1 secondary outcome
Patient satisfaction
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Management and Endoscopy, Gastrointestinal, run by The Affiliated Hospital of Qingdao University 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 28 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation related adverse events (time frame: During the anesthesia process). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2025.