Biliary and Pancreatic DiseasesNCT07017283
Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on on Perioperative Sedation Related Adverse Events in Elderly ERCP Patients
A study testing Tracheal intubation general anesthesia and Nasopharyngeal airway ventilation in people with Biliary and Pancreatic Diseases and Endoscopic Retrograde Cholangiopancreatography (ERCP), run by Gang Chen at 1 site in China.
Trial summary
This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Biliary and Pancreatic Diseases, Endoscopic Retrograde Cholangiopancreatography (ERCP)
- What is being tested?
- Tracheal intubation general anesthesia and Nasopharyngeal airway ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2025to 28 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 and above;
- ASA physical status≤III;
- Patients who scheduled for elective therapeutic ERCP (ERCP complexity grading system;
- Willing to provide informed consent (or by legal guardian/witness if applicable).
Who cannot join
- 1: Altered gastrointestinal anatomy, delayed gastric emptying, or gastric outlet obstruction； 2.Coagulopathy or epistaxis tendency; 3.Cardiac diseases (e.g., coronary artery disease, heart failure, arrhythmias); 4.Pulmonary diseases (e.g., asthma, COPD); 5.Prior hypersensitivity to anesthetic agents; 6.Active upper respiratory infection； 7.Severe liver and kidney diseases； 8.Difficult airway: Preoperative anesthesiologist assessment of difficult airway； 9.Psychiatric disorders, cognitive impairment, critical illness, or pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gang Chen contact
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhijiang, 310016
Xiaocui Lv, 13567109477, 3412008@zju.edu.cn
About this study
Official title: Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on Perioperative Respiratory Adverse Events in Elderly ERCP Patients: An Open-Label Randomized Controlled Trial
This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.
Read the detailed description
This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.
- Being tested
- Tracheal intubation general anesthesia, Nasopharyngeal airway ventilation
- Medical subject headings
- Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheal intubation general anesthesiaDevice
Endotracheal intubation with general anesthesia was administered to the patient during the ERCP procedure.
Nasopharyngeal airway ventilationDevice
Nasopharyngeal airway-assisted deep sedation was employed for the patient during the ERCP procedure.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | Not described Receives: Device: Tracheal intubation general anesthesia |
| Deep sedation | Experimental | Not described Receives: Device: Nasopharyngeal airway ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative sedation related adverse events
Measured: Perioperative period
Secondary outcomes (11)
recovery room time
Measured: Perioperative period
Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation
Measured: Perioperative
Second intubation after the tracheal intubation is removed
Measured: Perioperative
Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute)
Measured: Perioperative
Rating of reflux degree
Measured: perioperative
QoR-15 score on POD1
Measured: Postoperative day 1
Incidence of postoperative nausea and vomiting
Measured: postoperative day 1
respiratory failure/ARDS incidence
Measured: Perioperative
Postoperative cognitive function assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) has a total score of 30 points, with a score of ≥26 considered normal
Measured: Perioperative
patient/endoscopist satisfaction
Patient/endoscopist satisfaction with sedation type was assessed using a 10-point visual analog scale (VAS), where 1 represented the worst possible experience and 10 indicated the optimal experience
Measured: Perioperative
hospital stay duration
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start10 Nov 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 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 Biliary and Pancreatic DiseasesStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gang Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gang Chen, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017283
- Sponsor's protocol ID
- ERCP
- Status last verified
- Nov 2025
- First submitted
- 21 May 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lv X, Xu Y, Sun J, Liu H, Yu Y, Chen G. Effect of deep analgosedation vs. intubated general anesthesia on perioperative sedation-related adverse events in older adults undergoing ERCP: protocol for a randomized controlled trial. Front Med (Lausanne). 2026 Feb 26;13:1764649. doi: 10.3389/fmed.2026.1764649. eCollection 2026.
PubMed 41836944
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on Perioperative Respiratory Adverse Events in Elderly ERCP Patients: An Open-Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07017283
- Acronym / sponsor ID
- ERCP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Gang ChenUniversity, hospital or other
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 12 Jun 2025 (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 investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.
Detailed description
This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | Device: Tracheal intubation general anesthesia |
| Deep sedation | Experimental | Device: Nasopharyngeal airway ventilation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 and above;
- ASA physical status≤III;
- Patients who scheduled for elective therapeutic ERCP (ERCP complexity grading system;
- Willing to provide informed consent (or by legal guardian/witness if applicable).
Key exclusion criteria (1 listed)
- 1: Altered gastrointestinal anatomy, delayed gastric emptying, or gastric outlet obstruction； 2.Coagulopathy or epistaxis tendency; 3.Cardiac diseases (e.g., coronary artery disease, heart failure, arrhythmias); 4.Pulmonary diseases (e.g., asthma, COPD); 5.Prior hypersensitivity to anesthetic agents; 6.Active upper respiratory infection； 7.Severe liver and kidney diseases； 8.Difficult airway: Preoperative anesthesiologist assessment of difficult airway； 9.Psychiatric disorders, cognitive impairment, critical illness, or pregnancy.
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 |
|---|---|---|
| Tracheal intubation general anesthesiaEndotracheal intubation with general anesthesia was administered to the patient during the ERCP procedure. | Device | General anesthesia |
| Nasopharyngeal airway ventilationNasopharyngeal airway-assisted deep sedation was employed for the patient during the ERCP procedure. | Device | Deep sedation |
Primary outcome
Perioperative sedation related adverse events
Time frame: Perioperative period
11 secondary outcomes
recovery room time
Time frame: Perioperative period
Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation
Time frame: Perioperative
Second intubation after the tracheal intubation is removed
Time frame: Perioperative
Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute)
Time frame: Perioperative
Rating of reflux degree
Time frame: perioperative
QoR-15 score on POD1
Time frame: Postoperative day 1
Incidence of postoperative nausea and vomiting
Time frame: postoperative day 1
respiratory failure/ARDS incidence
Time frame: Perioperative
Postoperative cognitive function assessment (MoCA)
Time frame: Perioperative
patient/endoscopist satisfaction
Time frame: Perioperative
hospital stay duration
Time frame: Perioperative
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 18 Dec 2025.
- Derived from this study: PubMed 41836944Lv X, Xu Y, Sun J, Liu H, Yu Y, Chen G. Effect of deep analgosedation vs. intubated general anesthesia on perioperative sedation-related adverse events in older adults undergoing ERCP: protocol for a randomized controlled trial. Front Med (Lausanne). 2026 Feb 26;13:1764649. doi: 10.3389/fmed.2026.1764649. eCollection 2026.
- Individual participant dataSharing planned: Yes
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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.
Gang Chen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheal intubation general anesthesia and Nasopharyngeal airway ventilation in people with Biliary and Pancreatic Diseases and Endoscopic Retrograde Cholangiopancreatography (ERCP), run by Gang Chen 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 4 inclusion and 1 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 18 Dec 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?
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 Xiaocui Lv (+8613567109477, 3412008@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative sedation related adverse events (time frame: Perioperative period). 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 NCT07017283, 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 18 Dec 2025.