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Recruiting NCT07017283

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

No phase Interventional Biliary and Pancreatic Diseases Endoscopic Retrograde Cholangiopancreatography (ERCP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tracheal intubation general anesthesia, Nasopharyngeal airway ventilation.
Who it may be relevant to
Registry conditions: Biliary and Pancreatic Diseases, Endoscopic Retrograde Cholangiopancreatography (ERCP). Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device Tracheal intubation general anesthesia
    Endotracheal intubation with general anesthesia was administered to the patient during the ERCP procedure.
  • Device Nasopharyngeal airway ventilation
    Nasopharyngeal airway-assisted deep sedation was employed for the patient during the ERCP procedure.

Primary outcome measures

  • Perioperative sedation related adverse events [Time frame: Perioperative period]
Secondary outcome measures (11)
  • 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]

Eligibility criteria

Inclusion criteria：

  • 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou

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. PMID 41836944

Identifiers

NCT: NCT07017283 · ERCP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗