Do Preoperative Carbohydrate Drinks Prevent Preoperative Catabolism in Mothers Undergoing Elective Caesarean Section? A Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery.
研究概览
简要总结
The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on the incidence of urinary ketone bodies when compared to standard care in elective caesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.
详细描述
Patients requiring general anaesthetic for surgical procedures are asked to stop eating and drinking for several hours before the procedure. This is due to concerns that such patients are at risk of lung damage caused by stomach contents entering their lungs while they are asleep (aspiration of gastric contents).
However, fasting patients for long periods of time can lower their ability to heal well and slow their recovery from surgery. Fasting increases anxiety levels and leads to poor patient satisfaction with the care received.
Recent studies have showed that allowing patients to drink clear, easily absorbed sugar rich liquids (carbohydrate drinks) until two hours prior to their anaesthetic does not expose them to extra risks while preventing the deleterious effects of starvation.
Carbohydrate drinks with a few other measures aimed at facilitating early recovery after surgeries are collectively termed Enhanced recovery after surgery (ERAS). The benefits and safety of enhanced recovery have been demonstrated in patients undergoing major bowel surgery and have been widely adopted. However, so far, no studies have been conducted to determine if these results apply to mothers undergoing planned caesarean sections. We hope to address this gap in the knowledge with our proposed study.
All mothers undergoing a planned caesarean section in the Princess Royal Maternity (PRM) will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care. Information collected from the groups will be compared to evaluate the expected benefits and risks. The study will continue until the target sample size of 100 mothers in each of the two study groups is reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research midwives will attend consent, randomise, collect baseline data and provide the accompanying information and carbohydrate sachets to subjects. The research fellows will be blinded but will collect the data for participants. The research midwives will complete study compliance. To achieve this, participants will bring to ward a completed compliance form ( given at randomisation) in a sealed envelope this will ensure the research investigators remain blinded during their pre op assessments and data collection.
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Mother scheduled for elective caesarean delivery at the Princess Royal Maternity Unit, Glasgow.
排除标准
- •Patient refusal
- •Severe oesophageal reflux disease (persistent daytime and night-time reflux in association with documented structural damage i.e. Barrett's Oesophagus.)
- •Diabetes mellitus requiring treatment beyond dietary modulation
- •Unable to consent
- •Patients undergoing general anaesthetic should be excluded from the study.
- •Anticipated complex caesarean section patients.
研究组 & 干预措施
Interventional
Mothers will be given six sachets of carbohydrate powder to be mixed in water . Instructions will be given to have two sachets in 800ml water at 10pm the night before and one sachet in 400ml water at 6 am on the morning of surgery. The order of the list will be decided at 8.45am on the morning of surgery by the surgical team. Mothers scheduled to have surgery later than 11am will be given a further sachet at 9.30am. Mothers scheduled for surgery after 1pm will be given a sachet at 9am and 11am.
干预措施: Vitaflow Preload (Dietary Supplement)
Standard Care
Standard fasting instructions will given to mother:
Food until midnight before surgery 800ml water at 10pm night before surgery 400ml water at 6 am morning of surgery The order of the list will be decided at 8.45am on the morning of surgery by the surgical team.
Mothers scheduled to have surgery later than 11am will be given a further 400ml water at 9.30am. Mothers scheduled for surgery after 1pm will be given 400ml water at 9am and 11am.
结局指标
主要结局
Incidence of urine ketone body levels at catheterisation prior to elective caesarean delivery.
时间窗: From insertion of urinary catheter until 5 minutes post urinary catherisation
After bladder catheterisation, urine will be tested for ketone bodies (Ketostix, Bayer)
次要结局
- Preoperative thirst(On arrival to theatre - 5 minutes duration for questioning)
- Preoperative hand grip strength(On arrival to theatre and immediately prior to discharge from recovery room - 4 hour duration)
- Length of hospital stay(From admission to hospital until the date of discharge or date of death from any cause, whichever came first, assessed up to two weeks duration)