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

NCT ID: NCT05842720

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-09-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

retrospective

Consecutive patients with ASA score≥3 that underwent unsedated colonoscopy from May 2021 to August 2022 at Sheba medical center were identified by search of the computerized endoscopy database). Following an informed consent, patients were interviewed over the phone using a structured questionnaire. To assess their satisfaction, a standard Likert scale between 1 (unsatisfied) to 5 (very satisfied) was administered. Additional assessment included the maximum level of pain experienced at any point during the procedure (between 1-no pain) to 5-severe pain), and whether they would choose to perform future procedures without sedation in the future. Patients were also asked if they were able to return on the same day to their routine daily function and activities

Group Type: ACTIVE_COMPARATOR

un-sedated colonoscopies

Intervention Type: PROCEDURE

un-sedated colonoscopies in high risk patients with ASA\>=3

prospective

High risk patients scheduled for an anesthesiologist-assisted sedated-colonoscopy in Sheba medical center, were contacted during their clinic visit or by phone to receive explanation about the option to enroll in this unsedated colonoscopy study.

After obtaining informed consent, patients' Anxiety trait was assessed with the help of State-Trait Anxiety Inventory (STAI) questionnaire [8] in order to assess their level of anxiety and to investigate its predictive utility for their success in undergoing the unsedated procedure. Upon completion of the procedure in the same satisfaction questionnaire was administered, as detailed above for the retrospective part

Group Type: ACTIVE_COMPARATOR

un-sedated colonoscopies

Intervention Type: PROCEDURE

un-sedated colonoscopies in high risk patients with ASA\>=3

Interventions

un-sedated colonoscopies

un-sedated colonoscopies in high risk patients with ASA\>=3

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sheba medical center Tel Hashomer

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-7848-20-ML-CTIL

Identifier Type: -

Identifier Source: org_study_id