Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on on Perioperative Sedation Related Adverse Events in Elderly ERCP Patients

Gang Chen

Status: Enrolling

Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP); Biliary and Pancreatic Diseases

Treatments: Device: Nasopharyngeal airway ventilation; Device: Tracheal intubation general anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07017283

ERCP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

General anesthesia

Active Comparator group

Treatment:

Device: Tracheal intubation general anesthesia

Deep sedation

Experimental group

Treatment:

Device: Nasopharyngeal airway ventilation