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临床试验/NCT06680297
NCT06680297招募中不适用

A Pilot Study on Preoperative Carbohydrate Loading in Adolescent Idiopathic Scoliosis Surgery: the Impact on Safety and Enhanced Recovery

University of Malaya2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Improvement in bowel function by measuring days of first flatus

研究概览

简要总结

The goal of this interventional study is to learn if carbohydrates loading improves overall outcome in adolescent patient undergoing scoliosis curgery

The main questions of the study are as follows:

  1. Does carbohydrates loading improves gastrointestinal related problems such as improvement in return of bowel function measured by first passage of flatus, reduce constipation by patient's time to first bowel opening and reduce incidence of post post operative nausea and vommiting
  2. Does carbohydrates loading reduces length of hospital stay and patient's overall condition in term of anxiety, thirst and hunger
  3. Does carbohydrates loading affects gastric residual volume by measuring residual gastric volume with ultrasound

详细描述

Preoperative carbohydrate loading is strongly recommended by ESPEN as part of the clinical nutrition in surgery guideline. However, the implementation in clinical setup halted due to several limitations such as cost consuming, unfamiliar with new protocol and lack of expertise. Furthermore, there are no studies for preop carbohydrate loading in AIS as most preop carbohydrate loading is administered as a package for ERAS protocol. Thus, a strong level of evidence is necessary to propel a change in practice. As such, it is important to establish the relationship between carbohydrate loading before surgery and the impact on perioperative outcome.

Understanding the potential benefits of this nutritional intervention in the adolescent scoliosis population could contribute to the ongoing efforts to optimize surgical care in these patients. Although preoperative carbohydrates loading has strong recommendation in spinal fusion ERAS protocol, the level of evident is still scarce, more so in idiopathic scoliosis. In a systematic review, it has also stated that its limitation as most of the literature is largely retrospective studies with non-randomised data and cohort studies lacking formal control groups (Gadiya et al., 2021). Moreover, evidence on other benefits for carbohydrates loading in scoliosis surgery is still lacking such as its impact on pain, return of bowel function and post op nausea and vomiting.

This prospective study seeks to fill this knowledge gap by evaluating the influence of preoperative carbohydrate loading on postoperative outcomes in adolescents undergoing scoliosis surgery. We hypothesize that preoperative carbohydrate loading will be associated with an expedited return of bowel function, a reduced incidence of PONV, a shorter length of hospital stays, improvement in patient general wellbeing and no risk for aspiration. The objectives of this study are threefold. The primary goal of our study is to identify whether there is a significant improvement in the return of bowel function measured by flatus, reducing constipation by days of bowel opening and incidence of postoperative nausea and vomiting for patients receiving carbohydrate loading in comparison with patient that do not receive carbohydrate loading. Secondary objective also include carbohydrate loading and its effect on reducing length of hospital stay undergoing scoliosis surgery as well as patient overall condition in term of thirst, hunger and lethargy. The third objective is to measure the residual gastric volume using ultrasound before induction of anaesthesia.

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
Single (Investigator)

入排标准

年龄范围
10 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient diagnosed with idiopathic scoliosis undergoing single-staged posterior spinal fusion
  • •Age between 10 to 19 years old
  • •ASA 1 & 2

排除标准

  • •Patient diagnosed with diabetes mellitus (either type I or type II)
  • •Patient with intellectual disability
  • •American Society of Anesthesiologists (ASA) class 3 and above
  • •Significant risk of aspiration (diagnosed with hiatal hernia, presence of GERD, BMI > 35 kg/m2 , poor GCS, swallowing abnormality, gastrointestinal abnormality)

研究组 & 干预措施

Carbohydrates loading

Active Comparator

Participants will be given 10mls/kg of Nestle Resource carbohydrates drink a night before operation and 5mls/kg of Nestle Resource carbohydrates drink 2 hrs before operation

干预措施: Carbohydrates loading (Dietary Supplement)

Control group

Placebo Comparator

Participants will undergo standard 6 hrs fasting with 2hr clear water before operation

干预措施: Control group (Dietary Supplement)

结局指标

主要结局

Improvement in bowel function by measuring days of first flatus

时间窗: From post operation till patient discharge from hospital up to 1 week

Numbers of days when patient has start passing flatus post operation

Improvement in constipation

时间窗: From post operation till patient discharge from hospital up to 1 week

The number of day when patient start to pass motion after operation

Post op nausea vomiting

时间窗: Post operation within 48hours

number of nausea and vomiting

次要结局

  • Length of hospital stay(From post operation till patient discharge from hospital up to 1 week)
  • anxiety, thirst, hunger(Before induction of anaesthesia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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