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

Sponsor

Sheba Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT05842720

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction	Procedure: un-sedated colonoscopies	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 1, 2021

Actual Primary Completion Date :

Aug 31, 2022

Actual Study Completion Date :

Sep 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

satisfaction rate [up to 1 week after the date of the procedure]
Overall satisfaction score as assessed by Likert scale post-procedure

Secondary Outcome Measures

Recovery time after the procedure [up to 24 hours after the procedure]
the time lapse between extraction of colonoscope from the rectum and discharge of the patient from the Endoscopy recovery unit.
Complications or adverse effects rates during the procedure [from the beginning of the procedure until the end of 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)
Complete examination rates [from the beginning of the procedure until the end of the procedure]
how many examination were completed up to cecum intubation without need for sedation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Patients that are planned to go through both gastroscopy and colonoscopy procedures.
Patients with known adhesions and/or prior small bowel obstructions.
Patients that are planned to have a complicated procedure (complicated polypectomy etc).
Patients that are not able to give their consent with a full understanding of the procedure.
Patients that are pregnant.
Patients with a heart rate above 120 bpm or less than 40 bpm at the baseline as measured before starting the procedure.
Patients with a systolic blood pressure above 180mmHg or bellow 90mmHg as measured at the baseline before starting the procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba medical center Tel Hashomer	Ramat Gan		Israel	5262000

Sponsors and Collaborators

Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sheba Medical Center

ClinicalTrials.gov Identifier:

NCT05842720

Other Study ID Numbers:

SHEBA-7848-20-ML-CTIL

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 6, 2023