Effects of Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section. A Double-Blind Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.
详细描述
Carbohydrate (sugar-containing) nutritional supplements have become a routine part of the package of care for people undergoing planned surgical procedures. the investigator wanted to discover whether carbohydrate supplements are a useful part of care packages used by doctors to improve recovery after planned cesarean section.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women undergoing elective caesarean section
- •Term gestational age (37+0 to 41+6 weeks)
- •Singleton gestation
排除标准
- •Women with gestational diabetes and diabetes mellitus
- •Fetal intrauterine growth restriction
- •Ante-natally detected congenital anomaly which will require admission to the neonatal nursery
- •Women who received steroids within the past 7 days prior to delivery
- •Women who did not complete a gestational diabetes screening test
研究组 & 干预措施
preoperative carbohydrate loading
Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia
干预措施: preoperative carbohydrate loading (Drug)
Placebo
The control group will receive plain water with the same volume and timing of treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Length of hospital stay
时间窗: 3 weeks
Number of days in the hospital for each participant between the groups.
次要结局
- Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale(ist 24 hours postoperative)
- neonatal blood glucose concentration at four and ten hours of age(24 hours post operative)
- Neonates with plasma glucose level of less than 45 mg/dL between the groups(ist 24 hours postoperative)
- number of participants experienced nausea(24 hours postoperative)
研究者
hany farouk
Principal Investigator
Aswan University Hospital