NCT05842720

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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

Conditions

• Patient Satisfaction

Interventions

Type	Name	Description
PROCEDURE	un-sedated colonoscopies	un-sedated colonoscopies in high risk patients with ASA\>=3

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-08-31
• Completion: 2022-09-01
• First posted: 2023-05-06
• Last updated: 2023-05-06

Locations

1 site across 1 country: Israel