Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389045
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-04-24
Brief Title:
Propofol Infusion-Based Sedation on Anesthesia-Related Adverse Events in Endoscopic Ultrasonography
Sponsor:
Samsun University
Organization:
Samsun University
Study Overview
Official Title:
Effect of Propofol Infusion-Based Sedation on Anesthesia-Related Adverse Events in Endoscopic Ultrasonography A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hospitals 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 patients recovery time from anesthesia In addition bolusinfusion 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None