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.
