Deep analgosedation versus endotracheal intubation anesthesia for elderly ERCP patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.