Preoperative Carbohydrate Drink Prior to Elective Caesarean Section
Từ khóa
trừu tượng
Sự miêu tả
Patients recruited to the study will be randomised to one of 3 groups.
Group 1 will receive standard care as per our current practice. This includes fasting from solids for 6 hours prior to surgery and clear fluids for up to 2 hours prior to surgery.
Group 2 will receive a carbohydrate (CHO) drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this CHO drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.
Group 3 will receive an apple juice drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this apple juice drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.
Before the start of surgery, the patients non-dominant hand grip strength will be assessed using the dynamometer. Their subjective sense of thirst and hunger will be assessed. Their fasting times for food and fluids will be recorded. The patients' blood glucose will be measured from a blood sample as their intravenous cannula is inserted. The maternal urinary ketones will be measured from a urine sample upon insertion.
The neonatal blood cord glucose will be measured from both an arterial and venous cord blood sample after delivery. This will be performed by the trained anaesthesia research fellow. Should hypoglycemia be identified, the hospital's neonatal hypoglycemia algorithm will be followed appropriately.
The patients will be followed up at 24 hours by an outcome assessor blinded to the group allocation. Numerical rating scale (NRS) pain scores, postoperative nausea and vomiting and quality of recovery will be assessed at the patients beside. All neonates will be followed up to calculate admissions to neonatal unit and the number of glucose sachets required for hypoglycemia.
ngày
| Xác minh lần cuối: | 06/30/2020 |
| Đệ trình đầu tiên: | 11/07/2019 |
| Đăng ký ước tính đã được gửi: | 11/07/2019 |
| Đăng lần đầu: | 11/11/2019 |
| Cập nhật lần cuối được gửi: | 07/15/2020 |
| Cập nhật lần cuối đã đăng: | 07/16/2020 |
| Ngày bắt đầu nghiên cứu thực tế: | 01/19/2020 |
| Ngày hoàn thành chính ước tính: | 12/29/2020 |
| Ngày hoàn thành nghiên cứu ước tính: | 12/29/2020 |
Tình trạng hoặc bệnh tật
Can thiệp / điều trị
Dietary Supplement: Carbohydrate drink
Giai đoạn
Nhóm cánh tay
| Cánh tay | Can thiệp / điều trị |
|---|---|
| Placebo Comparator: Water Patients will be allowed to drink water up to 2 hours before their caesarean section. | |
| Active Comparator: Carbohydrate drink Patients will be allowed to drink a designated carbohydrate drink up to 2 hours before their caesarean section. | |
| Active Comparator: Apple juice Patients will be allowed to drink apple juice up to 2 hours before their caesarean section. |
Đủ tiêu chuẩn
| Tuổi đủ điều kiện để học | 18 Years Đến 18 Years |
| Giới tính đủ điều kiện để nghiên cứu | Female |
| Chấp nhận tình nguyện viên lành mạnh | Đúng |
| Tiêu chí | Inclusion Criteria: - Elective caesarean section for singleton pregnancy under neuraxial anaesthesia. - Subjects able to give informed consent and willing to comply with the study protocol. - Subjects must be greater than 18 years old. Exclusion Criteria: - Diabetes Mellitus - including gestational diabetes. - Known foetal abnormality. - General anaesthesia. - Gestation < 37 weeks. - Steroids received within 4 days of delivery. - Low birth weight 2.5 kg (IUGR) - BMI > 40 kg/m2 |
Kết quả
Các biện pháp kết quả chính
1. Neonatal cord blood glucose [0 hours]
Các biện pháp kết quả thứ cấp
1. Neonate tolerating 1st oral feeding. [0-2 hours]
2. Number of neonatal rescue oral glucose sachets given. [6 hours]
3. Neonate requiring ICU admission and treatment for hypoglycemia [6 hours]
4. Maternal blood glucose [0 hours]
5. Maternal urinary ketones [0 hours]
6. Maternal subjective sense of thirst prior to the start of caesarean section. [0 hours]
7. Maternal subjective sense of hunger prior to the start of caesarean section. [0 hours]
8. Maternal quality of recovery [24 hours]
9. Resumption of oral diet post caesarean section. [24 hours]
10. Resumption of fluids post caesarean section. [24 hours]
11. Post-operative nausea and vomiting (PONV) [24 hours]
12. PONV requiring treatment [24 hours]
13. Pain scores [24 hours]
14. Breastfeeding success [24 hours]
