Driving Skills Recovery Following Procedural Sedation for Gastrointestinal Endoscopy: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Median number of summated deviations
研究概览
简要总结
This is a prospective cohort study that will analyze psychomotoric recovery using a commercially available driving simulator following sedation for endoscopic procedures in subjects undergoing elective outpatient endoscopic procedures. Patients receiving both propofol based sedation and well as those receiving a combination of fentanyl and midazolam will be studied. Baseline data will be obtained after training on the simulator. Following the procedure and after meeting standard discharge criteria, the subjects will undergo the same driving simulation to ascertain psychomotoric recovery.
详细描述
Procedural sedation for ambulatory endoscopy procedures is delivered millions of times per year in the United States. Current standard of care necessitates the presence of a responsible adult to take the patient from the endoscopic facility back home and to observe the patient. In addition, patients are frequently advised not to drive until the morning after the procedure. This recommendation holds true whether the procedure was performed in the morning or afternoon. Current data regarding psychomotoric recovery following procedural sedation for gastrointestinal endoscopy is quite limited. Moreover there are no data utilizing a driving simulator to gauge psychomotoric recovery in this setting.
The proposed study is a prospective, open label cohort study enrolling patients at the Cleveland Clinic's advanced endoscopy unit.
Inclusion criteria are: English speaking patients 18 years or older who currently hold a valid driver's license, are able to give informed consent and are undergoing either anesthesiologist directed propofol sedation (Group1) or a combination of an opioid and benzodiazepine targeting moderate sedation (Group 2) for elective outpatient procedures including advanced (endoscopic retrograde cholangiopancreatography, endoscopic ultrasonography, endoscopic submucosal dissection, deep enteroscopy) and non-advanced (esophagogastroduodenoscopy, colonoscopy) procedures.
Exclusion criteria include: inpatients, patients with altered mental status, legal blindness, physical limitations that would not make them candidates to be tested in the driving simulator, American Society of Anesthesiologists (ASA) ≥ 4 , urgent procedures, systolic hypotension defined as a systolic blood pressure < 90 mmHg and patients in whom English is not the primary language.
Upon enrollment the following information will be obtained: Age, gender, BMI, intended procedure, Mallampati score, medications and allergies, comorbidities (obesity, history of cardiac disease, renal insufficiency, chronic obstructive pulmonary disease, obstructive sleep apnea, diabetes mellitus, and the use of medications narcotics, antidepressants and sedatives.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking subjects ≥18 years
- •Currently hold a valid driver's license
- •Able to give informed consent
- •Undergoing either anesthesiologist directed propofol sedation targeting deep sedation (Group1) or a combination of an opioid and benzodiazepine targeting moderate sedation (Group 2) for elective outpatient procedures
排除标准
- •Inpatients
- •Subjects patients with altered mental status
- •Subjects with legal blindness
- •Physical limitations that would not make them candidates to be tested in the driving simulator
- •American Society of Anesthesiologists physical classification score ≥ 4
- •Urgent procedures
- •Systolic hypotension defined as a systolic blood pressure ≤ 90 mmHg
- •Subjects in whom English is not a primary language.
结局指标
主要结局
Median number of summated deviations
时间窗: From end of procedure until discharge, typically less than 4 hours
Simulator Results - number of off road crashes, number of collisions with vehicles and other roadway objects, number of times over the posted speed limit, total number of times the center line was crossed, total number of times the driver went off the road, number of times turn signal not used or used inappropriately).
Center Lane Errors
时间窗: From end of procedure until discharge, typically less than 4 hours
Simulator Results - Percentage of time center lane crossed during simulated driving scenario
Mean brake pedal reaction time (seconds)
时间窗: From end of procedure until discharge, typically less than 4 hours
Simulator Results - Mean brake pedal reaction time (seconds) during simulated driving scenario
Median minimum distance to vehicle (feet).
时间窗: From end of procedure until discharge, typically less than 4 hours
Simulator Results - Median minimum distance to vehicle (feet) during simulated driving scenario
次要结局
- Body mass index(At baseline)
- Total propofol dose(From beginning to end of endoscopy, typically less than 2 hours)
- Age(At baseline)
- Mallampati score(At baseline)
- Total midazolam dose(From beginning to end of endoscopy, typically less than 2 hours)
- Total fentanyl dose(From beginning to end of endoscopy, typically less than 2 hours)
研究者
John Vargo
John J. Vargo, MD, MPH; Director Endoscopy Operations, Cleveland Clinic
The Cleveland Clinic