Clinical trial NCT06316648: Whey Intake Blood Glucose, Fasting, Thirst, Nausea and Vomiting Levels of Patients Undergoing Elective Hip Fracture Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Hip Fracture Surgery
Keywords: Whey,
Fasting
Thirsts
Nausea
Vomiting
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multidisciplinary cooperation was performed for the effective and efficient conduct of the study. In determining the patients to administer Whey according to the study's inclusion criteria, an orthopedic and traumatological specialist's support was received, as well as that of an anesthesiologist. On the other hand, the researcher cooperated with a nutritionist in preparing and assessing the Whey content to be administered to the patients.
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: blood glucose
timeFrame: 12 week
Secondary outcomes:
measure: Fasting, Thirst
timeFrame: 12 week
measure: Nausea and Vomiting
timeFrame: 12 week
Other outcomes:
Locations:
city: Kayseri̇
country: Turkey
facility: Erciyes University
state: Talas
Study officials:
References:
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citation: Noblett SE, Watson DS, Huong H, Davison B, Hainsworth PJ, Horgan AF. Pre-operative oral carbohydrate loading in colorectal surgery: a randomized controlled trial. Colorectal Dis. 2006 Sep;8(7):563-9. doi: 10.1111/j.1463-1318.2006.00965.x.
citation: Deng Y, Fang Y, Li H, Chen J, An J, Qiao S, Wang C. A preoperative whey protein and glucose drink before hip fracture surgery in the aged improves symptomatic and metabolic recovery. Asia Pac J Clin Nutr. 2020;29(2):234-238. doi: 10.6133/apjcn.202007_29(2).0004.
citation: 6. Güzeler N. Esmek E. Kalender M. Peyniraltı Suyu Ve Peyniraltı Suyunun İçecek Sektöründe Değerlendirilme Olanakları. Çukurova Tarım Ve Gıda Bilimleri Dergisi.2017:32(2); 27-36