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临床试验/CTRI/2025/04/084327
CTRI/2025/04/084327尚未招募不适用

Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance Assessed using HOMA -IR in Elective Lower Segment Cesarean Section Patients done under Spinal Anesthesia - A Randomized Prospective Parallel Arm Double Blinded Controlled Trial

Dr Hariharan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2027年1月5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
60
试验地点
1
主要终点
The primary outcome will be pregnant women perioperative insulin resistance will be evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR) index

研究概览

简要总结

A single dose of carbohydrate reduces postoperative insulin resistance, glyconeogenesis, glycogenolysis, and lipolysis

It also minimizes muscle protein catabolism and allows glucose accumulation in the liver to be stored as glycogen.

The aim of preoperative administration of carbohydrate solution before surgical intervention is to increase glycogen storage in the body and reduce possible tissue damage and insulin resistance.

Administration of these liquids during the perioperative period has been reported to increase patient comfort, reduce the patient’s anxiety level, and shorten the hospital stay.

Aim is To compare the effect of preoperative oral carbohydrate drink on insulin resistance using HOMA –IR in elective lower segment caesarean section patients under spinal anaesthesia with ERAS recommended perioperative fasting guidelines vs conventional fasting method.Single centre – parallel arm , prospective study

Double blinded (outcome assessor/primary investigator)

Randomized controlled trial

Group I included patients randomized to receive oral carbohydrate drinks (CHO)

Group II included patients randomized to serve as controls and receive standard fasting (SF).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 44.00 Year(s)(—)
性别
Female

入选标准

  • Singleton term gestation Uncomplicated pregnancy.
  • patients scheduled for an elective cesarean delivery.
  • planned under spinal anesthesia (ASA II).

排除标准

  • Patient not willing for study ASA 3 and above.

结局指标

主要结局

The primary outcome will be pregnant women perioperative insulin resistance will be evaluated by the homeostatic model assessment of insulin resistance (HOMA-IR) index

时间窗: 2nd day of POD

次要结局

  • Gastric volume assessments will be done before spinal anaesthesia, in order to assess the gastric content prior to anaesthesia done by separate experienced anaesthesiologist.(Neonatal indices regarding the well-being of the newborn were recorded from medical records, including one-minute & five-minute APGAR scores recorded at delivery)

研究者

发起方
Dr Hariharan
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Hariharan ps

A4 Hospital and Fertility centre

研究点 (1)

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