Ignite Creation Date:
2024-05-06 @ 6:57 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05842720
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-04-06
Brief Title:
Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure
Status:
COMPLETED
Status Verified Date:
2023-03
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:
This study aim to examine the safety and feasibility of unsedated colonoscopy in patients with high risk for sedation ASA score3
Detailed Description:
This was a two-part study Part 1 was a retrospective study of patients with ASA score3 that underwent unsedated colonoscopy from May 2021 to August 2022 at Sheba medical center who were contacted up to one year after the procedure and were asked to assess their satisfaction and pain level on a standard Likert score from 1-5 Part 2 was a prospective study which included high risk patients who were scheduled for an anesthesiologist-assisted sedated-colonoscopy and who consented to undergo an unsedated procedure The primary outcome was patients satisfaction during and up to one week after the procedure Pain level adverse events and hemodynamic parameters during the procedure were secondary outcomes Baseline State-Trait Anxiety Inventory STAI questionnaire were also administered and results examined vis-à-vis satisfaction scores
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