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临床试验/NCT06316648
NCT06316648已完成不适用

The Effect of Preoperative Oral Whey Intake on Blood Glucose, Fasting, Thirst, Nausea and Vomiting Levels of Patients Undergoing Elective Hip Fracture Surgery: A Randomized Controlled Study

TC Erciyes University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2021年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
blood glucose

研究概览

简要总结

Whey Intake Blood Glucose, Fasting, Thirst, Nausea, Vomiting Elective Hip Fracture Surgery

详细描述

The prolonged fasting period before surgery causes symptoms such as anxiety, hypoglycemia, increase in gastric volume, decrease in pH value, development of insulin resistance, thirst, feeling of hunger, hypovolemia, dehydration, headache, etc. in patients. For these reasons,Guidelines for Preoperative Nutrition in Children and Adults prepared by the European Society of Anesthesiologists, it was stated that solid foods six hours before surgery and clear liquids two hours before surgery could be consumed.In the accelerated recovery protocol (Enhanced Recovery After Surgery- ERAS), the preoperative fasting period before anesthesia is stated as two hours for liquid foods and six hours for solid foods (high level of evidence, strong level of recommendation).

Carbohydrate drinks act as a main meal in patients, increasing satiety and reducing insulin resistance. Carbohydrate drinks also increase the feeling of thirst and help to improve thirst sensitization. Therefore, it is recommended that patients should drink them before surgery. Carbohydrate-rich liquids that can be drunk up to two hours before elective surgery reduce fasting, thirst and postoperative insulin resistance and make the person feel good (evidence level 1++, recommendation grade A).

Hip fracture is a problem that increases with advanced age. It seems likely that the encounter with this problem and its costs will increase in the world due to the prolongation of life expectancy. Furthermore, the increased risk of osteoporosis due to increased sedentary life and malnutrition contribute to the development of this problem.Surgery is required in the treatment of 98% of elderly patients with hip fractures. Besides, the presence of chronic diseases in most elderly patients increases the risk of mortality and morbidity. Therefore, the risk of perioperative complications in elderly patients with hip fractures is a serious clinical problem.

Whey is a translucent, greenish-yellow liquid protein source obtained from the precipitation of casein in cheese or casein production. Similar in composition to milk, whey contains about half of the milk dry matter, almost all of the milk sugar, about 1/5 of the proteins and most of the B vitamins. After technological developments, whey is no longer considered as a waste but is used in industry. Many clinical trials have shown that whey is effective in the treatment of cancer, AIDS, hepatitis B, heart diseases and osteoporosis. 6 Prolonged preoperative fasting in elderly patients causes metabolic changes, and postoperative nausea and vomiting cause changes in blood glucose and prolonged hospital stay. When the literature was reviewed, it was observed that the number of studies on whey in preoperative oral carbohydrate intake, which is included in ERAS protocols in orthopedic patients, is very limited and academic studies are needed. This study was conducted to determine the effect of whey, as a different liquid other than oral carbohydrate liquids, on patients hunger, thirst, blood sugar and nausea and vomiting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 60 years of age or older,
  • Belonging to ASA II or III group,
  • Having HA surgery for the first time, and
  • Having the surgery performed under spinal anesthesia.

排除标准

  • Diabetes Mellitus,
  • Undergoing emergency surgery,
  • Having gastrointestinal and endocrine problems,
  • Using medications that may affect blood sugar,
  • Patients with psychiatric/neurological disorders, patients who need any fluid or blood in the preoperative period, whey allergy, and patients who have intensive care in the postoperative period

研究组 & 干预措施

control group

Active Comparator

At 00:00 the night before the surgery, the researcher told the patients in the control group that they could have fruit juice/water if they wanted and waited for 10 minutes. The researcher then initiated the restriction process by informing the patients that they could no longer have food/water. Fasting, thirst, blood glucose and nausea-vomiting evaluations applied to the patients in the intervention group were also performed on the patients in the control group at the same hours. IV fluid therapy was not administered to both groups before surgical intervention.

干预措施: control group (Procedure)

whey intake

Experimental

Since whey powder contains 73.45 grams of carbohydrate per 100 grams, whey was given to the patients in this study, unlike OCS (Oral Carbohydrate Solution), as it met the requirement in the ERAS protocol that at least 45 g of oral carbohydrate solution can be given two hours before surgery. It was prepared at the bedside by the first investigator for the patients in the oral whey intervention group by mixing 54 grams of 70% demineralized whey powder taken from the herbalist into 600 ml of drinking water six hours before the surgery, and the patients were given 400 ml six hours before the surgery and 200 ml two hours before the surgery. They were given ml and allowed to drink. Before the surgery, the patients' hunger, thirst, blood glucose and nausea and vomiting levels were evaluated.

干预措施: whey intake group (Dietary Supplement)

结局指标

主要结局

blood glucose

时间窗: 12 week

The value was measured with 1ml of blood from the patient's fingertip.

次要结局

  • Nausea and Vomiting(12 week)
  • Fasting, Thirst(12 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

HÜMEYRA YÜKSEL

Principal Investigator

TC Erciyes University

研究点 (2)

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