NCT06216977撤回不适用
CODA-POP Surgery: Clears On the Day of Anesthesia Permissible up to One-Hour Prior to Surgery - A Prospective Randomized and Blind Trial
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年1月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Residual Gastric Volume in mL/kg
研究概览
简要总结
The purpose of this study is to assess whether residual gastric volumes in patients who receive clear liquids one hour prior to time of procedure is non-inferior compared to patients who are NPO past midnight, to compare efficiency and flexibility of operating room scheduling between two fasting conditions, to assess patient satisfaction and post-operative nausea, vomiting, pain, hunger and thirst.
and to assess wound healing and post-operative complication rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing laparoscopic cholecystectomy during the day or night of a weekday (including those consented on a Friday who get postponed to a weekend surgery start time).
- •Modified rapid sequence intubation (mRSI)
排除标准
- •History of reflux disease
- •History of hiatal hernia
- •History of esophageal disease
- •History of gastroparesis
- •Known history of difficult airway or planned fiberoptic intubation
- •HbA1c greater than 12
- •Pregnant women
- •Procedures conducted on weekends and holidays
- •Emergency or non-elective procedures
结局指标
主要结局
Residual Gastric Volume in mL/kg
时间窗: At time of intubation (about 1 hour after fluid intake)
次要结局
- Number of participants with observed emesis(During perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours))
- Number of participants with production of oropharyngeal secretions(During the perioperative period which includes preoperative, intraoperative and post operative time (about 4 hours))
- Number of participants with wound dehiscence(postoperative follow up appointment (about 1 month after surgery))
- Number of participants with subjective post-operative nausea(within 24 hours of surgery)
- Overall patient satisfaction as assessed by the Press-Ganey Questionnaire(within 48-96 hours of surgery)
- Number of participants with intraoperative complications(From start of surgery to end of surgery)
- Number of participants with subjective pre-operative nausea(at baseline)
- Amount of post-operative pain medications needed(at first clinic appointment (about 1 month after surgery))
研究者
yafen liang
Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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