RECoVER: Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time to discharge
研究概览
简要总结
The purpose of this research is to compare the effect of different procedural sequences on the time to recovery and the propofol sedation requirements in patients undergoing bidirectional endoscopy with sedation.
The two sequences are:
- Colonoscopy followed by Esophagogastroduodenoscopy (EGD)
- EGD followed by Colonoscopy
详细描述
120 patients will be asked to participate in the trial. The subject will undergo both procedures in the order assigned by the randomization sheet. During the procedure, the endoscopist and anesthesiologists will collect data including but not limited to vital signs (heart rate, blood oxygen level, blood pressure) and level of sedation through the Bispectral Index Monitor (BIS). After completing the procedures, the patient will be approached in the recovery room by the study coordinator who will administer the Modified Post Anesthesia Discharge Scoring System (M-PADSS) scale every 5 minutes until a score of 9 or higher is obtained on two consecutive attempts. 24 hours following the procedure, the study coordinator will call the patient in order to assess the patient's cognitive function and drowsiness after they were discharged from the endoscopy unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age above 18
- •Scheduled EGD and colonoscopy on the same day
- •Scheduled to Anaesthesiologist administered sedation during the procedure
排除标准
- •Age below 18
- •Known allergy or adverse reaction to Propofol, Midazolam or opioid medication (ex: fentanyl)
- •Medical contraindication to Anaesthesia
- •Sleep apnea
- •American Society of Anesthesiologists classification (ASA) >3
- •Inpatient status
- •Pregnant or lactating women
- •Known cirrhosis
- •Chronic Kidney Disease (stage 4 or 5)
- •Known psychological disorder
- •Known cognitive dysfunction
- •Significant gastroparesis
- •Gastric outlet obstruction
- •Known or suspected bowel obstruction or perforation
- •Having a stoma
- •Compromised swallowing reflex or mental status
- •Prior colon resection or gastric surgery
- •Age above 75 years
- •Chronic use of more than 1 psychoactive drug (Benzodiazepines, Tricyclic antidepressants, antipsychotics, selective serotonin receptor inhibitors, serotonin norepinephrine receptor inhibitors, Monoamine oxidase inhibitor)
结局指标
主要结局
Time to discharge
时间窗: 1 hour
Time from end of procedures to patient discharge
次要结局
- Cognitive impairment(24 hours)
- Depth of anesthesia(1 hour)
- Propofol dose(1 hour)
- Adverse events during sedation(1 hour)
研究者
Ala'a Sharara, MD
Professor of Medicine
American University of Beirut Medical Center