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.

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

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Procedure: un-sedated colonoscopies

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

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 5262000
    • Sheba Medical Center Tel Hashomer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: un-sedated colonoscopies; un-sedated colonoscopies in high risk patients with ASA>=3
Active Comparator: 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	Procedure: un-sedated colonoscopies; un-sedated colonoscopies in high risk patients with ASA>=3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
satisfaction rate	Overall satisfaction score as assessed by Likert scale post-procedure	up to 1 week after the date of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Estimate): May 4, 2023

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SHEBA-7848-20-ML-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No