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 Details — Status: Completed

Administrative data

• NCT number: NCT05842720
• Other study ID #: SHEBA-7848-20-ML-CTIL
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2023
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 1, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Only adults (>18 years of age) that will be assessed as high risk and require an anesthesiologist clinic assessment prior to the procedure and anesthesiologist presence during the procedure.

Exclusion Criteria:

1. Patients that are planned to go through both gastroscopy and colonoscopy procedures.

2. Patients with known adhesions and/or prior small bowel obstructions.

3. Patients that are planned to have a complicated procedure (complicated polypectomy etc).

4. Patients that are not able to give their consent with a full understanding of the procedure.

5. Patients that are pregnant.

6. Patients with a heart rate above 120 bpm or less than 40 bpm at the baseline as measured before starting the procedure.

7. Patients with a systolic blood pressure above 180mmHg or bellow 90mmHg as measured at the baseline before starting the procedure.

Related Conditions & MeSH terms

• Patient Satisfaction

Intervention

Procedure:
• un-sedated colonoscopies
un-sedated colonoscopies in high risk patients with ASA>=3

Locations

Country	Name	City	State
Israel	Sheba medical center Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfaction rate	Overall satisfaction score as assessed by Likert scale post-procedure	up to 1 week after the date of the procedure
Secondary	Recovery time after the procedure	the time lapse between extraction of colonoscope from the rectum and discharge of the patient from the Endoscopy recovery unit.	up to 24 hours after the procedure
Secondary	Complications or adverse effects rates during the procedure	perforations, post-polypectomy bleeding, bradycardia (defined as pulse rate under 40 bpm), low oxygen saturation (defined as saturation below 90% under nasal oxygen cannula) or hemodynamically instability (defined as systolic blood pressure below 90mmHg and diastolic blood pressure below 60mmHg)	from the beginning of the procedure until the end of the procedure
Secondary	Complete examination rates	how many examination were completed up to cecum intubation without need for sedation	from the beginning of the procedure until the end of the procedure