Sheba medical center Tel Hashomer
Ramat Gan, 5262000, Israel
NCT Number: NCT05842720
This study aim to examine the safety and feasibility of unsedated colonoscopy in patients with high risk for sedation (ASA score≥3).
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Notify Me18 year–99 year
All sexes
Interventional
Not applicable
Ramat Gan, 5262000, Israel
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
un-sedated colonoscopies in high risk patients with ASA>=3
Time frame: up to 1 week after the date of the procedure
Overall satisfaction score as assessed by Likert scale post-procedure
Time frame: 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.
Time frame: 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)
Time frame: 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
Sheba Medical Center
Other Gov
Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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