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临床试验/CTRI/2024/12/078536
CTRI/2024/12/078536尚未招募不适用

A Randomized Controlled Trial Comparing The Effect of Preoperative Oral Carbohydrate Intake Versus Conventional Fasting Protocol In Intraoperative Core Body Temperature Of Parturients Undergoing Elective Lower Segment Casearean Section

Bharati Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2025年1月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140
试验地点
1
主要终点
Effect of preop carbohydrate drink on intraoperative maternal core body temperature

研究概览

简要总结

In this prospective randomised controlled trial we will compare the effect of preoperative oral carbohydrate intake  versus  conventional fasting protocol  on  the intraoperative core maternal body temperature undergoing elective cessarean section ,

Parturient will be divided into two groups ,Group 1: will recieve 250ml of carbohydrate drink 2 hour prior LSCS,

Group 2: will be kept overnight fasted as per hospital protocol .

Intraoperative tympanic membrane temperature will be recorded at 30,60,90 minutes after spinal anaesthesia ,Changes in the tympanic membrane temperature at each above mentioned time points wll be compared in both (preoperative carbohydrate group and fasting group),

Incidence of shivering,, cold perception score and side effects  will be noted as secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Parturients of age 20-40 years posted for elective lower segment cessarean section under spinal anaesthesia.
  • Gestational age 38-40 weeks 3) A body mass index of upto 30kg/m2.

排除标准

  • Parturients refusal
  • Body temp more than 38 degrees
  • additional comorbidities.

结局指标

主要结局

Effect of preop carbohydrate drink on intraoperative maternal core body temperature

时间窗: Effect of preop carbohydrate drink on intraoperative maternal core body temperature at 30, 60 and 90 min after spinal

次要结局

  • incidence of shivering and cold perception score, side effect if any(continuously throughout the surgery)

研究者

发起方
Bharati Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Anjali Rao

Bharati Vidyapeeth deemed to be university,

研究点 (1)

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