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临床试验/NCT05494268
NCT05494268已完成不适用

Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis

Karamanoğlu Mehmetbey University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
The comparison of the changes in thiol disulfide values between the groups

研究概览

简要总结

The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on thiol disulfide homeostasis when compared to standard care in elective cesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.

详细描述

The concept of enhanced recovery after surgery (ERAS) has been gradually extended from surgery to the field of obstetrics. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. Although these effects of the preoperative carbohydrate loading has been studied, the thiol disulfide homeostasis effects after carbohydrate loading has not been investigated yet. Thiol-disulfide homeostasis (TDH) plays a critical role in the mechanisms of antioxidant defense, detoxification, apoptosis, regulation of enzyme activities, transcription, and cellular signal transduction. Since the newborns are very susceptible to harmfull effects of reactive oxygen species, the effect of carbohydrate loading on the reactive oxygen species gain importance.

All mothers undergoing a planned caesarean section in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Term pregnancies,
  • Planned elective ceserean sections,
  • Under spinal anesthesia,
  • Pregnants who can read and write Turkish.

排除标准

  • Preterm pregnants,
  • Pregnants with reflux,
  • hiatus hernia,
  • enteral nutrition,
  • alcohol or substance abuse,
  • prolonged delivery,
  • systemic chronic diseases,
  • malignancy,
  • GDM,eclampsia,preeclampsia,
  • fetal anomaliy,
  • prolonged delivery

研究组 & 干预措施

Experimental ( Carb Group)

Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery.

干预措施: Carbohydrate (Drug)

结局指标

主要结局

The comparison of the changes in thiol disulfide values between the groups

时间窗: From beginning to two hours after the surgery

The native thiol, total thiol, disulfide, native thiol/total thiol ratio, disulfide/native thiol ratio, and disulfide/total thiol ratio will be determined.

次要结局

  • Total ephedrine usage(From beginning to the end of the surgery)
  • Incidence of intraoperative hypotension(From beginning to the end of the surgery)

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozlem Dulger

Assist Prof

Karamanoğlu Mehmetbey University

研究点 (1)

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