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Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure

Patient Satisfaction Clinical Trial

Official title:
Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure.

Clinical Trial Summary

This study aim to examine the safety and feasibility of unsedated colonoscopy in patients with high risk for sedation (ASA score≥3).

Clinical Trial Description

This was a two-part study: Part 1 was a retrospective study of patients with ASA score≥3 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05842720
Study type Interventional
Source Sheba Medical Center
Contact
Status Completed
Phase N/A
Start date May 1, 2021
Completion date September 1, 2022
View Details
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