跳至主要内容
临床试验/CTRI/2021/10/037208
CTRI/2021/10/037208尚未招募不适用

Preoperative carbohydrate loading to maintain normothermia in children under anaesthesia : A prospective randomised controlled trial

Neerja Bhardwaj Department of Anaesthesia and Intensive Care1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年10月20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
116
试验地点
1
主要终点
Incidence of hypothermia

研究概览

简要总结

Anaesthesia and surgery hamper the intrinsic mechanisms of thermoregulation, thus leading to unavoidable hypothermia. Maintenance of  normothermia is therefore of paramount importance. In patients undergoing elective caesarean section under neuraxial anaesthesia, oral carbohydrate loading has been shown to reduce incidence of shivering and is conducive to maintenance of normothermia. The proposed randomised controlled study will be conducted in ASA 1 and 2 children, 2-10 yrs old. Children would be randomly allocated to one of the two study groups using computer generated random number table –Oral carbohydrate (OC), Oral placebo (OP) group. The incidence of hypothermia, shivering and temperature difference between 2 groups will be noted.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
2.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Surgery lasting for more than 30 minutes to less than 3 hours.

排除标准

  • Laparoscopic surgeries, Contraindication to fluid intake 2 hours prior to surgery, Surgeries lasting for more than 3 hours, refusal to consent.

结局指标

主要结局

Incidence of hypothermia

时间窗: Intraoperatively

次要结局

  • Incidence of postoperative shivering(Upto 2 hours postoperatively)
  • Temperature difference between the two groups(Intraoperatively)

研究者

发起方
Neerja Bhardwaj Department of Anaesthesia and Intensive Care
申办方类型
Research institution and hospital

研究点 (1)

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