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临床试验/CTRI/2023/06/053420
CTRI/2023/06/053420尚未招募不适用

The effect of preoperative oral carbohydrate loading on body temperature in elective caesarean delivery under spinal anaesthesia: A randomized controlled trial

Karnataka Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年12月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Decreased change in the body temperature intraoperatively

研究概览

简要总结

Hypothermia after surgery is a common complication. This leads to redistribution of central heat to the periphery and overall heat loss. The clinical consequences include patient discomfort, shivering, platelet dysfunction, coagulopathy, and increased vasoconstriction associated with a higher risk of wound infection. Nutrient induced thermogensis may prevent intraoperative hypothermia. Oral carbohydrate loading two hours before surgery may facilitate body temperature maintenance during caesarean section.

Aim:  Oral carbohydrate loading two hours prior to caesarean delivery may decrease the change in the body temperature intraoperatively.

Objectives:

  • To evaluate the effect of preoperative oral carbohydrate loading on intraoperative body temperature.

  • To assess effect of carbohydrate drink intraoperative and postoperative shivering.

  • To assess effect of carbohydrate drink on incidence of nausea and vomiting in postoperative period.

Materials and methods: A Prospective Randomized controlled trial.

Sample size: 30 patients in each group.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • ASA II undergoing elective caesarean section under spinal anaesthesia.

排除标准

  • 1 Preoperative hyperthermia (>38°C) or hypothermia (<36 °C) 2 BMI>30 Kg/m2 3 Patients with diabetes mellitus, hypertension, hypothyroid or hyperthyroid, anemia 4 Patients with delayed gastric emptying, hyperemesis gravidarum until late pregnancy, or consumption of drugs that affect gastrointestinal motility within 3 days before surgery.
  • 5 Patients who failed to drink the carbohydrate drink as prescribed before surgery 6 Patients with ear disease 7 Surgical time >1.5 hours 8 Intraoperative blood transfusion.

结局指标

主要结局

Decreased change in the body temperature intraoperatively

时间窗: -15 minutes prior to caesarean delivery | -Immediately after induction | -At the end of delivery | -1 hour 30 minutes after delivery

次要结局

  • • Decreased incidence of intra operative & postoperative shivering(• Decreased incidence of nausea & vomiting in postoperative period)

研究者

申办方类型
Government medical college

研究点 (1)

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