Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries

Официальное название

A Randomised Controlled Study of Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries

Обзор

Surgery is known to be associated with stress response affecting in a negative way the clinical outcome and patient experience. The stress response includes both sympathetic nervous system activation and systemic inflammatory response. The pituitary- sympathetic one leads to a number of metabolic changes as hyperglycemia, nitrogen loss and lipolysis on the other hand the systemic inflammatory response aggravates the perioperative metabolic changes. One of components of ERAS is preoperative carbohydrate load. Oral carbohydrate was associated with attenuation of the postoperative metabolic stress response. Nitrate rich drinks before exercises have a promising impact due to improving blood flow, mitochondrial efficiency, glucose uptake and the sarcoplasmic calcium handling all of which maximize resistance to fatigue and improved exercise performance.

Вмешательства

• Препарат Low-concentration carbohydrate and nitrates
  Patients in the CHON group will be given 400 mL of a clear carbohydrate drink (12.5 g/100 mL maltodextrin, 50 kcal/100 mL) and 2 capsules of beet root extract 1 gm on the evening before surgery (8 hours) and another 200 mL of the carbohydrate drink and 1 capsule of beet root extract 1 gm on the day of surgery, 2 h before anesthesia induction.
• Препарат Low-concentration carbohydrate
  Patients in the CHO group will be given the same carbohydrate drink in the CHON group with 2 placebo capsules with the evening drink and one with the morning drink.
• Другое Water with placebo capsules
  Patients in the W group will be given equivalent volume of drinking water with placebo capsules by evening and in the morning of surgery.

Первичные конечные точки

• The length of hospital stay (Days) [Срок оценки: The study end point will be 7 days from the operation or when patient will be discharged from hospital which of which will be earlier.]

Критерии участия

Критерии включения

• Patients ageing from 18 to 60 years,
• American Society of Anesthesiologists (ASA) physical status I,II
• scheduled for elective open gynecological surgeries

Критерии исключения

Patients with

• Previous chemotherapy treatment,
• Disseminated malignant disease,
• BMI more than 40,
• Known allergy to one or more of the study medications
• Refusal to participate in the study
• Patients diagnosed with diabetes milieus either type I or type II,
• Patients with previous bariatric surgeries
• Patients under medications that delay gastric emptying (tricyclic anti-depressants, chronic use of laxatives)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Ain-Shams University Hospitals — Cairo

Идентификаторы

NCT: NCT04962776 · IRB 6379/2021/FMASU MD261/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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