The Effect of Combined General-epidural vs General Anaesthesia on Postoperative Intestinal Function Recovery and Infection in Neonates and Infants Undergoing Gastrointestinal Surgery: a Prospective, Randomised, Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- Postoperative intestinal function recovery for neonates and infants undergoing gastrointestinal surgery. Which anesthetic method be superior and favoured as normal practice general or combined general and epidural anesthesia.
研究概览
简要总结
Sixty neonates and infants will be enrolled and randomised into two groups of n=30 each . For their surgical procedures, one group general (GA) anaesthesia the second group will receive a combined general and epidural anaesthesia (CGEA).
Anaesthetic technique:
Patients in the GA group will be induced with intravenous propofol (2-4 mg.kg-1) and fentanyl (2-4 µg.kg-1) and will receive rocuronium bromide (0.5 mg.kg-1) to facilitate endotracheal intubation. Anaesthesia will be maintained with sevoflurane (2-3%) in an air/oxygen mixture as well as intravenous fentanyl as required.
In the (CGEA) 0.5 ml.kg-1 of 0.25% bupivacaine will be injected into the epidural catheter, followed by a continuous infusion of 0.1% bupivacaine at a rate of 0.2 mg.kg-1.hr-1 for up to 48 hours postoperatively. Assessment of anaesthetic efficacy will be measured Intraoperative care vital signs. And will continuously be monitored with a Datex AS/3 (Engestrom®, Helsinki, Finland) monitor.
The use of antibiotic prophylaxis will be determined by the degree of bowel contamination during surgery, with the commonest regimen consisting of penicillin, gentamicin and metronidazole will be administered. Antibiotics will be continued for 36-48 hours postoperatively to prevent infection arising from the disturbed bowel flora.
Postoperative care, following surgery, will be conducted. The feeding volume will be increased in steps as long as the volume of regurgitated fluid will be less than 20% of the administered breast milk or formula volume. Full feeding will define as oral tolerance of at least 80% of daily maintenance volume. In cases of abdominal distension or vomiting, feeding will withheld until symptom resolution. The nasogastric tube will be removed on bowel function restoration The CRIES score will be use to assess the severity and duration of postoperative pain during the patients' NICU stay. If the CRIES score is ≥4, fentanyl will be continuously intravenously infused in both study group. Fentanyl will be also administered to CGEA patients who experienced pain despite a continuous epidural infusion at 1-5 µg.kg-1.h-1. The amount of fentanyl required for adequate postoperative pain relief will be recorded in both groups.
详细描述
After approval off the local Ethical Committee of Bnai Zion Hospital, Haifa, Israel and informed parental consent obtained for each participant. Sixty small infants who undergoing GI surgery will be enrolled in this study.
The inclusion criteria are neonates or infants requiring the following major intestinal procedures: duodenoduodenostomy or duodenojejunostomy for duodenal atresia, ileocaecal resection for intestinal volvulus, ileostomy or colostomy closure for congenital anorectal malformations, and corrective surgery for Hirschsprung's disease. The exclusion criteria are concurrent coagulopathies, sepsis, vertebral column malformations, neurological disease, immunocompromise with or without leukopenia, and intestinal necrotising enterocolitis. Patients will be also excluded if they will require exploratory laparotomy or emergent intestinal surgery.
Sixty premature, ex-premature, and full-term neonates and infants meeting the above criteria will enrolled in the study, patients will randomised into two groups of n=30 each ( according to a computer program ) . For their surgical procedures, the first group will receive general anesthesia (GA group), whereas the second group receive combined general and epidural anesthesia (CGEA group).
Anesthetic technique Patients in the GA group will be induced with intravenous propofol (2-4 mg.kg-1) and fentanyl (2-4 µg.kg-1) and receive rocuronium bromide (0.5 mg.kg-1) to facilitate endotracheal intubation. Anaesthesia will be maintained with sevoflurane (2-3%) in an air/oxygen mixture as well as intravenous fentanyl as required.
Patients in the CGEA group will be induce as above in addition to receiving epidural anaesthesia as follows: A 20G epidural catheter (B. Braun Medical Ltd., Melsungen, Germany) through a 19G Crawford epidural needle, so that its tip lays between the desired T5 and T10 spinal segments. Correct catheter placement will be confirmed by portable epidurography after filling the catheter with 0.5 ml iohexol (Omnipaque® 300, Nycomed, Oslo, Norway). A test dose of 0.1 ml.kg-1 of 1% lidocaine with 1:200 000 adrenaline will be administered, and the result and effects on heart rate (HR) and the ST segment will be noted. If the HR increases by at least 20% above baseline and/or ST segment changes will be observed, the catheter will be withdrawl and re positioned. 0.5 ml.kg-1 of 0.25% bupivacaine will be injected into the epidural catheter, followed by a continuous infusion of 0.1% bupivacaine at a rate of 0.2 mg.kg-1.hr-1 for up to 48 hours postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates or infants requiring the following major intestinal procedures: duodenoduodenostomy or duodenojejunostomy for duodenal atresia,
- •ileocaecal resection for intestinal volvulus,
- •ileostomy or colostomy closure for congenital anorectal malformations,
- •corrective surgery for Hirschsprung's disease. emergent intestinal surgery.
排除标准
- •The exclusion criteria are concurrent coagulopathies,
- •vertebral column malformations,
- •neurological disease,
- •immunocompromise with or without leukopenia,
- •intestinal necrotising enterocolitis.
- •Patients will be also excluded if they required exploratory laparotomy or or emergent intestinal surgery
结局指标
主要结局
Postoperative intestinal function recovery for neonates and infants undergoing gastrointestinal surgery. Which anesthetic method be superior and favoured as normal practice general or combined general and epidural anesthesia.
时间窗: upto 20 days postoperative
The outcomes measured to determine recovery of intestinal function recovery: 1. Time to first postoperative defecation measured in hours or days 2. Duration of nasogastric feeding measured in hours or days 3. Time to tolerance of full oral feeding measured in hours or days
次要结局
- Rate and sort of postoperative infection(upto 20 days postoperative)
研究者
MOSTAFA.SOMRI
Prof Mostafa Somri
Bnai Zion Medical Center