RecruitingNot ApplicableNCT07017283

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


Sponsor

Gang Chen

Enrollment

170 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Inclusion Criteria4

  • 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).

Exclusion Criteria1

  • : 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.

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Interventions

DEVICETracheal intubation general anesthesia

Endotracheal intubation with general anesthesia was administered to the patient during the ERCP procedure.

DEVICENasopharyngeal airway ventilation

Nasopharyngeal airway-assisted deep sedation was employed for the patient during the ERCP procedure.


Locations(1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhijiang, China

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NCT07017283