Intravenous Amino Acid Infusion in Mothers Before and During Cesarean Delivery: Effects on Maternal and Neonatal Temperature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- neonatal rectal temperature
研究概览
简要总结
Introduction: Intravenous infusion of amino acids during cesarean delivery in mothers and neonates improves neonatal growth. Amino acid before and during anesthesia also prevents hypothermia and associated untoward effects.
Method: After ethical approval, this prospective randomized double blind controlled study is being conducted in the university hospital of BPKIHS. Seventy six parturients (ASA 1 & 2) undergoing cesarean delivery without fetal distress, intrauterine growth retardation, congenital malformation or premature labor will be enrolled.
For a period starting from approximately one hour prior to spinal anesthesia, Group 1 and Group 2 patients will receive 200 ml of amino acid and lactated ringers solution respectively at 2 ml/kg/hr. The ambient operating room temperature will be maintained near 23º C. No heating methods will be applied apart from covering with a blanket.
Primary outcome measure will be neonatal rectal temperature at 0, 5 and 10 min after birth. Secondary outcome measures will be APGAR scores and suckling reflex in the newborn, change in rectal temperature relative to baseline and discomfort related to cold sensation in the mother and the occurrence of shivering both in the mother and newborn.
详细描述
Review of literature:
Hypothermia is common during peri-operative period (1). It can lead to shivering (2), sympathetic stimulation (3), ischemic cardiac events (3), coagulation disturbances (4,5) delayed recovery from anesthesia (6,7), altered immune system with impaired wound healing (8,9) and prolonged hospitalization (9).
Amino acid infusion before and during surgery is known to prevent peri-operative hypothermia as a result of increased thermogenesis (10,11) without additional sympatho-adrenal activity (12). The mechanism is based on nutrient induced thermogenesis; i.e., nutrient intake, especially proteins and amino acids, stimulates resting energy expenditure and heat production (13). This effect is more pronounced during general anesthesia than neuraxial block (14). It has also been proved that amino acid infusion before and/or during anesthesia and surgery decreases intra-operative blood loss (15), improves peri-operative recovery (16) and shortens the duration of hospital stay (17).
The safety of intravenous amino acid infusion during cesarean delivery was long ago established (18,19).While maternal intravenous administration of amino-acids led to increased levels of amino acids in maternal venous blood and fetal umbilical cord blood plasma, there was no increase in fetal uptake of amino acids.
The safety of amino acid in the first day of life after delivery has also already been proved (20,21). It has been used to achieve positive protein balance in the immediate postoperative period in neonates undergoing abdominal surgery (20). Aggressive therapy of intravenous amino acid in preterm infants during 12 hrs to two weeks after birth enhanced their growth and improved their nutritional status during hospitalization (21).
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, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturients belonging to American Society of Anesthesiologists physical status I and II scheduled for elective cesarean delivery were enrolled.
排除标准
- •Pregnancy with fetal distress, intrauterine growth retardation, congenital malformation or premature labor were excluded.
研究组 & 干预措施
Amino acid
Intravenous infusion of amino acid solution started approximately one hour prior to spinal anaesthesia after recording the baseline vital parameters. Each patient in experimental group received a total of 200 ml at 2 ml/kg/min.
干预措施: Amino acid solution (Drug)
Ringer's Lactate solution
Intravenous infusion of Ringer's lactate solution started approximately one hour prior to spinal anaesthesia after recording the baseline vital parameters. Each patient in experimental group received a total of 200 ml at 2 ml/kg/min.
干预措施: Ringer's lactate solution (Drug)
结局指标
主要结局
neonatal rectal temperature
时间窗: 10 min after delivery
次要结局
- APGAR score of newborn(0 min, 5 min, 10 min after birth)
- length of hospital stay of newborn(up to 72 hours)
- number of newborn with adequate suckling reflex(10 min after birth)
- number of neonates who developed shivering(during the first 10 min after birth)
- scale assessing the discomfort related to cold sensation in mother(intraoperative period during spinal anesthesia)
- number of mothers who developed shivering(intraoperative period during spinal anesthesia)
- length of hospital stay of mother(up to 72 hours)
- change in maternal rectal temperature compared to baseline(before infusion (baseline) and at the end of infusion of 200 ml of study solution)
- maternal rectal temperature(at the time of delivery during intraoperative period (usually within 30 minutes))
研究者
Krishna Pokharel
Dr (MD)
B.P. Koirala Institute of Health Sciences