Consented Unsedated Endoscopy in High Risk Patients That Require Anesthesiologist Observation During the Procedure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- satisfaction rate
研究概览
简要总结
This study aim to examine the safety and feasibility of unsedated colonoscopy in patients with high risk for sedation (ASA score≥3).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: un-sedated colonoscopies (Procedure)
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
干预措施: un-sedated colonoscopies (Procedure)
结局指标
主要结局
satisfaction rate
时间窗: up to 1 week after the date of the procedure
Overall satisfaction score as assessed by Likert scale post-procedure
次要结局
- Recovery time after the procedure(up to 24 hours after the procedure)
- Complete examination rates(from the beginning of the procedure until the end of the procedure)
- Complications or adverse effects rates during the procedure(from the beginning of the procedure until the end of the procedure)