Oral caffeine versus lactulose for enhancing gastrointestinal recovery in patients after elective abdominal surgeries under general anesthesia - CAF-LAC TRAIL - A randomised controlled study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
Postoperative ileus is a common complication following elective abdominal surgery and is characterized by delayed return of gastrointestinal motility, abdominal distension, nausea, discomfort, and prolonged hospital stay. Several factors contribute to postoperative ileus, including bowel manipulation during surgery, anesthetic effects, inflammatory responses, sympathetic stimulation, and opioid use. Early restoration of gastrointestinal function is essential to improve postoperative recovery and reduce hospitalization.
Caffeine, a methylxanthine compound, has been shown to stimulate gastrointestinal motility through antagonism of adenosine receptors and stimulation of enteric nervous system activity. Lactulose, a non-absorbable disaccharide, is commonly used as an osmotic laxative to promote bowel movement in postoperative patients. Although both agents are used to enhance bowel motility, direct comparison between oral caffeine and lactulose in postoperative gastrointestinal recovery has not been adequately studied.
The CAFLAC Trial (Caffeine Versus Lactulose Trial) is a prospective randomized controlled trial conducted in the Department of General Surgery at AIIMS Gorakhpur. The study aims to compare the effectiveness of oral caffeine versus lactulose in enhancing gastrointestinal recovery in patients undergoing elective abdominal surgery under general anesthesia. The primary outcome will be time to first bowel movement, while secondary outcomes include time to first flatus, time to first stool passage, tolerance to oral feeding, and duration of hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18–65 years Undergoing elective abdominal surgery under general anesthesia ASA physical status I–III Able to tolerate oral intake postoperatively Expected hospital stay more than 24 hours Willing to provide written informed consent.
排除标准
- •History of inflammatory bowel disease Patients undergoing bowel resection and anastomosis Known allergy or intolerance to caffeine or lactulose Patients on regular laxatives or prokinetics Severe hepatic, renal, or cardiac dysfunction Pregnant or lactating women Patients with caffeine dependence (greater than 400 mg/day intake).
研究者
Dr Nikhil B
AIIMS GORAKHPUR
