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临床试验/NCT04962776
NCT04962776招募中4 期

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
90
试验地点
1
主要终点
The length of hospital stay (Days)

研究概览

简要总结

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.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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)

研究组 & 干预措施

Low-concentration carbohydrate and nitrates group (CHON group )

Active Comparator

干预措施: Low-concentration carbohydrate and nitrates (Drug)

Low-concentration carbohydrate group (CHO group)

Active Comparator

干预措施: Low-concentration carbohydrate (Drug)

W group

Placebo Comparator

干预措施: Water with placebo capsules (Other)

结局指标

主要结局

The length of hospital stay (Days)

时间窗: 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.

The length of hospital stay (Days)

次要结局

未报告次要终点

研究者

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

Ibrahim Mamdouh Esmat

Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Ain Shams University

研究点 (1)

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