NCT01346917已完成不适用
Prospective Randomized Controlled Study for the Effect of Intravenous Lidocaine on the Tolerability of Early Oral Feeding After Laparoscopic Colorectal Surgery in Patients With Colorectal Cancer
Kangbuk Samsung Hospital1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Prevalence of postoperative nausea and vomiting.
研究概览
简要总结
The purpose of this study is to determine whether intravenous lidocaine increase the tolerability of early oral feeding after laparoscopic colorectal surgery in patients with colorectal cancer.
- Degree of nausea/vomiting.
- Degree of postoperative pain and opioids requirement.
- Time to first flatus, time to first stool, time to tolerance of regular diet, rate of postoperative complications and duration of postoperative hospital stay.
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 (Participant)
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
- •Elective laparoscopic colorectal surgery for colorectal cancer.
- •Age > 18 years.
- •Informed consent.
排除标准
- •Allergy to local anesthetics.
- •Severe cardiovascular, hepatic, or renal diseases.
- •Pregnant or lactating patients.
- •Emergency surgery.
- •American Society of Anesthesiologists (ASA) class IV
研究组 & 干预措施
Lidocaine
Experimental
干预措施: Lidocaine (Drug)
Placebo
Placebo Comparator
干预措施: Normal saline (Drug)
结局指标
主要结局
Prevalence of postoperative nausea and vomiting.
时间窗: From day of surgery to sixth postoperative day.
Intolerance to early postoperative oral feeding is defined as the patient's having either nausea or vomiting, requiring that the patient be non-per oral status.
次要结局
- Time to first flatus.(From day of surgery to sixth postoperative day.)
- Time to first passage of stool.(From day of surgery to sixth postoperative day.)
- Degree of postoperative pain.(From day of surgery to sixth postoperative day.)
- Postoperative opioid consumption.(From day of surgery to sixth postoperative day.)
- Time to tolerance of regular diet(From day of surgery to sixth postoperative day.)
- Postoperative complications(From day of surgery to thirtieth postoperative day.)
- Duration of postoperative hospital stay.(From day of surgery until discharge, an expected average of nine days.)
研究者
HO Kim, MD
Assistant professor
Kangbuk Samsung Hospital
研究点 (1)
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