Propofol Infusion-Based Sedation on Anesthesia-Related Adverse Events in Endoscopic Ultrasonography

NCT06389045 | Completed

• 1 other identifier: EUS
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic ultrasonography (EUS) is an endoscopic procedure performed to investigate conditions affecting the stomach, liver, and bile ducts, as well as for therapeutic interventions. The complexity of EUS can vary significantly, with increased complexity affecting procedure duration, technical success, and the occurrence of adverse events. For the comfort of patients and the success of the procedure, these interventions are typically performed under anesthesia with procedural sedation. To enhance the success rate of the procedure, reduce the risk of side effects, and maximize patient comfort, EUS is generally performed under sedation according to the recommendations of the American Society of Anesthesiologists (ASA). During sedation, the aim is for the patient to be more relaxed and comfortable while maintaining spontaneous respiratory function. Preserving spontaneous respiratory parameters is crucial for procedural safety.

Conditions

Sedation Complication; Endoscopic Ultrasonography; Procedural Sedation

Keywords

Procedural Sedation; Sedoanalgesia; Endoscopic Ultrosonography

Outcome Measures

Primary Outcomes (1)

• Anesthesia related advers events

  arrhythmia, hypotension, desaturation, vomiting, patient movement, cough during EUS probe insertion, hiccups

  during the procedure

Secondary Outcomes (1)

• recovery time

  1 hour

Interventions

Procedural Sedation OTHER

Profopol Sedation in Endoscopic Ultrasonography

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo endoscopic ultrasonography (EUS) under procedural sedation

You may qualify if:

• Endoscopic ultrasonography (EUS) patients for procedural sedation

You may not qualify if:

• Patients who do not sign the consent form.
• Under the age of 18.
• Pregnancy.

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University Faculty of Medicine

Samsun, Turkey (Türkiye)

Location

Study Officials

• Caner Genc, M.D.

  Samsun University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: April 24, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 27, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

TU (1)