Profopol & Remifentanil Sedation in Endoscopic Ultrasonography

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06389045
Study type	Observational [Patient Registry]
Source	Samsun University
Contact	Caner Genc, M.D.
Phone	5444846865
Email	dr.canergenc@gmail.com
Status	Recruiting
Phase
Start date	April 24, 2024
Completion date	July 1, 2024

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Profopol and Remifentanil Sedation in Endoscopic Ultrasonography

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms