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Profopol and Remifentanil Sedation in Endoscopic Ultrasonography

Recruiting
18 - 75 years of age
Both
Phase N/A

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Overview

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.

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 details

Sedation Complication, Endoscopic Ultrasonography, Procedural Sedation

NCT06389045

Samsun University

15 May 2024

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