Construction and Effectiveness Evaluation of Painless Digestive Endoscopy Mode Led by Anesthesia Nurses Under the Guidance of Anesthesiologists

NCT06712264 | Completed DMC

• 1 other identifier: QYFYEC2024-234
• Study Type: observational
• Target: 18,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose is to verify the effectiveness and safety of the painless digestive endoscopy mode led by anesthesia nurses under the guidance of anesthesiologists.

Conditions

Pain Management; Endoscopy, Gastrointestinal

Keywords

Painless endoscopy; Anesthesia doctors guide anesthesia nurses; sedation

Outcome Measures

Primary Outcomes (1)

• Sedation related adverse events

  During and after the examination process summarized by the adverse event reporting tool, the incidence of adverse events such as hypotension, hypertension, tachycardia, bradycardia, arrhythmia, hypoxemia, apnea, coughing (continuous coughing without wheezing, considered as a single cough), and body movements (non directive limb movements) were recorded. The incidence of adverse events during painless endoscopic diagnosis and treatment by anesthesiologists and anesthesiologists, as well as the number and reasons for anesthesiologists seeking help from anesthesiologists, were also recorded

  During the anesthesia process

Secondary Outcomes (1)

• Patient satisfaction

  During surgery

Study Arms (2)

Exposed Group

Sedation administered by anesthetic nurses under the guidance of anesthesiologists

Unexposed Group

Sedation administered by anesthesiologists

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population undergoing gastrointestinal endoscopy examination at Qingdao University Affiliated Hospital from December 2024 to February 2025.

You may qualify if:

• Age ≥ 16 years old,
• no oral intake before surgery: liquid for 2 hours, solid for 6 hours.

You may not qualify if:

• American Society of Anesthesiology (ASA) classification greater than III,
• sleep apnea,
• allergies to soybeans, eggs, or peanuts,
• pregnancy,
• previous anesthesia related complications,,
• potential difficult ventilation,
• acute gastrointestinal bleeding,
• sub intestinal obstruction,
• severe chronic obstructive pulmonary disease (COPD)

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 2, 2024
• Study Start: December 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

CN (1)