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

NCT07017283 | Recruiting DMC

• 1 other identifier: ERCP
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biliary and Pancreatic Diseases; Endoscopic Retrograde Cholangiopancreatography (ERCP)

Outcome Measures

Primary Outcomes (1)

• Perioperative sedation related adverse events

  Perioperative period

Secondary Outcomes (11)

• recovery room time

  Perioperative period

• Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation

  Perioperative

• Second intubation after the tracheal intubation is removed

  Perioperative

• Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute)

  Perioperative

• Rating of reflux degree

  perioperative

Study Arms (2)

General anesthesia

ACTIVE COMPARATOR

Device: Tracheal intubation general anesthesia

Deep sedation

EXPERIMENTAL

Device: Nasopharyngeal airway ventilation

Interventions

Tracheal intubation general anesthesia DEVICE

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

General anesthesia

Nasopharyngeal airway ventilation DEVICE

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

Deep sedation

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• : 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.

Sponsors & Collaborators

• Gang Chen: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhijiang, 310016, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Central Study Contacts

Xiaocui Lv

CONTACT

+8613567109477; 3412008@zju.edu.cn

Gang Chen

CONTACT

chengang120@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 12, 2025
• Study Start: November 10, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)