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

NCT ID: NCT06389045

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2024-06-27

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.

Detailed Description

Within the scope of this study, patients undergoing endoscopic ultrasonography (EUS) under anesthesia in the endoscopy unit will be examined. We administered propofol infusion for procedural sedation for patients undergoing therapeutic EUS in our hospital's endoscopy unit. We aimed to evaluate the impact of this sedation method on anesthesia-related adverse events. The primary outcome of this study was to evaluate the anesthesia-related adverse events, which were defined as arrhythmia, hypotension, desaturation, vomiting, undesirable patient movement, coughing, and hiccups during EUS probe insertion. The secondary outcome was defined as the patient's recovery time from anesthesia. In addition, bolus/infusion drug doses used for anesthesia induction and maintenance, demographic data, EUS indications in patients, and comorbidities of patients were recorded.

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.

Conditions

Sedation Complication; Endoscopic Ultrasonography; Procedural Sedation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Procedural Sedation

Profopol Sedation in Endoscopic Ultrasonography

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsun University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caner Genc, M.D.

Role: PRINCIPAL_INVESTIGATOR

Samsun University

Locations

Samsun University Faculty of Medicine

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

EUS

Identifier Type: -

Identifier Source: org_study_id