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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06389045
Other study ID # EUS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 24, 2024
Est. completion date July 1, 2024

Study information

Verified date April 2024
Source Samsun University
Contact Caner Genc, M.D.
Phone 5444846865
Email dr.canergenc@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

The aim of this observational study is to investigate the safety and feasibility of sedation in patients undergoing endoscopic ultrasonography (EUS) in the endoscopy unit, where procedural sedation is administered for this purpose. Vital parameters will be recorded during the procedure and in the recovery unit. Data for the study will be obtained from nurse observation forms and anesthesia records found in patient files. It is an observational study of file scanning nature, which includes information contained in the files. Within the scope of this study, patients undergoing endoscopic ultrasonography (EUS) under anesthesia in the endoscopy unit will be examined. Parameters such as hypotension, desaturation, and vital signs will be recorded during or after the routinely administered sedation procedure. The primary objective of the study is to evaluate the prevalence of major anesthesia-related complications such as arrhythmias, hypotension, and vomiting (safety endpoint). The secondary objectives are as follows: (a) to assess the prevalence of inadequate sedation symptoms such as movement, coughing, and hiccupping (feasibility endpoint); (b) to determine the time taken to achieve the target level of sedation.


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 1, 2024
Est. primary completion date June 24, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Endoscopic ultrasonography (EUS) patients for procedural sedation Exclusion Criteria: - Patients who do not sign the consent form. - Under the age of 18. - Pregnancy.

Study Design


Intervention

Other:
Procedural Sedation
Profopol and Remifentanil Sedation in Endoscopic Ultrasonography

Locations

Country Name City State
Turkey Samsun University Faculty of Medicine Samsun

Sponsors (1)

Lead Sponsor Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anesthesia related major complications arrhythmias, hypotension, desaturation and vomiting 1 hour
Secondary The prevalence of symptoms of inadequate sedation movement, cough and hiccups 1 hour
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