跳至主要内容
临床试验/CTRI/2024/07/069976
CTRI/2024/07/069976招募中2/3 期

Effect of Carbohydrate Loading on Recovery of Patients undergoing Total Knee Replacement Surgery- A Randomised controlled trial

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月7日最近更新:

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Well-being of the patients – assessed using Numerical Rating Scale for Pain, Thirst and Hunger, weakness.

研究概览

简要总结

Recent evidence shows the advantages of carbohydrate loading in major surgeries especially gastrointestinal surgeries. The pathophysiological and metabolic changes in response to surgery can be diminished by introducing ways of decreasing inflammatory and metabolic response including insulin resistance. Patients undergoing total knee replacement surgeries are at a high risk for developing perioperative metabolic derangements and complications due to the advanced age and associated comorbidities. We expect that a simple measure like decreasing the fasting time and carbohydrate loading will decrease the metabolic and endocrine derangements by decreasing the insulin resistance, decreasing the inflammatory response. It will also decrease patient discomfort by reducing thirst, dehydration, hunger, pain and anxiety. Reduced protein catabolism will lead to improved muscle strength, decreased weakness and help in early ambulation.

Positive outcomes of the study will encourage introduction of a simple, efficacious and inexpensive clinical intervention in patients undergoing this major orthopedic surgery which demands early recovery and ambulation. Patients will have increased satisfaction without the risk of aspiration, decreased post-operative complications leading to early discharge and reduced length of hospital stay.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • After obtaining institute ethical clearance and informed written consent from all patients, the study will be conducted in ASA 1-2 patients who are posted for unilateral Total Knee Replacement surgery in 70 patients ages 18-70 years.

排除标准

  • Diabetes, obesity, reflux disease, patient on steroids, severe cardiac or renal disease.

结局指标

主要结局

Well-being of the patients – assessed using Numerical Rating Scale for Pain, Thirst and Hunger, weakness.

时间窗: preoperatively, 4 hrs and 24 hrs postoperatively

次要结局

  • 1.Insulin resistance and inflammatory markers (cortisol and IL-6)(2. Incidence of post-operative nausea and vomiting)

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sana Yasmin Hussain

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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