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

Completed

• Conditions: Sedation Complication; Procedural Sedation; Endoscopic Ultrasonography

• Registration Number: NCT06389045
• Lead Sponsor: Samsun University

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.

Study Timeline

• Study Start: 2024-04-24
• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-29
• Primary Completion: 2024-06-24
• Study Completion: 2024-06-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anesthesia related advers events	during the procedure	arrhythmia, hypotension, desaturation, vomiting, patient movement, cough during EUS probe insertion, hiccups

Secondary Outcome Measures

Name	Time	Method
recovery time	1 hour	Each patient was evaluated using the Post-Anesthetic Discharge Score (PADS)

Trial Locations

Locations (1)

Samsun University Faculty of Medicine; 🇹🇷 Samsun, Turkey