Dexamethasone in the Prevention of Post-spinal Paralytic Ileus After Cesarean Section, Does it Make a Difference: A Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- the time to first passage of flatus and or stool
研究概览
简要总结
Postoperative ileus is a perplexing problem for clinical surgeons. It occurs not only after abdominal surgery but also after any surgery that requires general anesthesia. Postoperative ileus is defined as the dysfunction of gastrointestinal motility after surgery, characterized by a decrease in, or stagnation of, intestinal peristalsis.
详细描述
Common clinical manifestations include abdominal pain, abdominal distention, nausea, vomiting, delayed flatus, delayed defecation, and inability to consume orally. Postoperative ileus is an uncomfortable experience, enhances the possibility of postoperative complications, prolongs hospital stay, and increases the economic burden. Postoperative gastrointestinal function recovery is of great concern. There is currently an urgent need to improve postoperative recovery of gastrointestinal function. The mechanism of Postoperative ileus varies, including autonomic regulation, inflammatory response, gastrointestinal hormones, and postoperative use of opioid drugs. Surgical gut damage destroys the intestinal barrier, stimulates the sympathetic and parasympathetic nervous systems, and enhances the release of inflammatory factors. These factors precipitate the occurrence of Postoperative ileus. The current use of laparoscopic techniques can reduce incision size and surgical trauma, enabling careful manipulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- ••All participants will sign an informed consent prior to inclusion in the study.
- •All patients 18-40 years of full-term singleton pregnancy (37-41 weeks).,
- •American Society of Anaesthesiologists (ASA) classification class I and II scheduled.
- •for elective or semi-elective surgery (category 3 and 4 Caesarean sections).
- •All patients under spinal anesthesia for a Single baby pregnancy of more than 32 weeks will be included in this study.
排除标准
- •will be patients' height < 150 or > 180 cm.
- •Body mass index (BMI) >35 kg m-
- •Contraindication or refusal to undergo regional anesthesia.
- •any cardiovascular disease including arrhythmias and severe stenotic valvular heart disease.any renal or hepatic diseased patients.
研究组 & 干预措施
Group C
Patients received 5 ml of IV normal saline as a placebo just before spinal anesthesia
干预措施: 0.9%sodium chloride (Drug)
Group D
Patients received IV dexamethasone 8 mg in 5ml normal saline 0,9%, just before spinal anesthesia.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
the time to first passage of flatus and or stool
时间窗: 24 hours postoperative
the time to first passage of flatus and or stool through the first 24 hours and the time of return of intestinal sounds,
次要结局
未报告次要终点
研究者
Ghada Mohammed AboelFadl
Principal investigator
Assiut University