MedDataX Logo

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

NCT ID: NCT07017283

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Biliary and Pancreatic Diseases Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

General anesthesia

Group Type ACTIVE_COMPARATOR

Tracheal intubation general anesthesia

Intervention Type DEVICE

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

Deep sedation

Group Type EXPERIMENTAL

Nasopharyngeal airway ventilation

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tracheal intubation general anesthesia

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

Intervention Type DEVICE

Nasopharyngeal airway ventilation

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gang Chen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gang Chen

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhijiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xiaocui Lv

Role: CONTACT

Phone: +8613567109477

Email: [email protected]

Gang Chen

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Xiaocui Lv

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ERCP

Identifier Type: -

Identifier Source: org_study_id