Deep analgosedation versus endotracheal intubation anesthesia for elderly ERCP patients
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 will see if deep analgosedation or endotracheal intubation general anesthesia leads to fewer sedation-related problems in people aged 60 and older undergoing therapeutic ERCP.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Sir Run Run Shaw Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhijiang) |
| Trial ID | NCT07017283 on ClinicalTrials.gov |
What this trial studies
This interventional study compares two anesthesia approaches—deep analgosedation with nasopharyngeal airway ventilation and general anesthesia with endotracheal intubation—in patients aged 60 and older undergoing elective therapeutic ERCP at Sir Run Run Shaw Hospital. Eligible participants have ASA physical status I–III and will receive the assigned airway and sedation strategy while perioperative sedation-related adverse events are recorded. Patients with difficult airway, significant cardiopulmonary disease, altered gastrointestinal anatomy, severe organ dysfunction, coagulopathy, active infection, or cognitive impairment are excluded. The trial aims to quantify rates of airway complications, hemodynamic instability, and other sedation-related adverse events between the two approaches.
Who should consider this trial
Good fit: People aged 60 or older with ASA status I–III who are scheduled for elective therapeutic ERCP and can provide informed consent are the intended participants.
Not a fit: Patients with difficult airways, significant cardiac or pulmonary disease, altered gastrointestinal anatomy, severe liver or kidney dysfunction, coagulopathy, active upper respiratory infection, cognitive impairment, or pregnancy are unlikely to benefit from this comparison and are excluded.
Why it matters
Potential benefit: If successful, the results could help lower sedation-related complications and improve safety for older adults undergoing therapeutic ERCP.
How similar studies have performed: Previous studies comparing deep sedation and general anesthesia for ERCP have reported mixed results—some show fewer airway events with intubation but increased hemodynamic effects—so definitive guidance is lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria： 1. Aged 60 and above; 2. ASA physical status≤III; 3. Patients who scheduled for elective therapeutic ERCP (ERCP complexity grading system; 4. Willing to provide informed consent (or by legal guardian/witness if applicable). Exclusion criteria： 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.
Where this trial is running
Hangzhou, Zhijiang
- Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhijiang, China (Recruiting)
Study contacts
- Study coordinator: Xiaocui Lv
- Email: 3412008@zju.edu.cn
- Phone: +8613567109477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.