The Impact of Preoperative Branched Chain Amino Acid Overloading on Insulin Resistance compared to Carbohydrate Overloading and Conventional Fasting in patients undergoing Laparoscopic Cholecystectomy An Open Labelled Randomised Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- To study the effect of Pre-operative Branched Chain Amino Acid Overloading on Post-operative Insulin Resistance and Post-Operative Hyperglycaemia in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint will be the successful demonstration of effect of BCAA preloading compared to carbohydrate overloading and conventional overnight fasting on Post-operative Insulin Resistance and post-operative hyperglycaemia
研究概览
简要总结
Insulin resistance after surgery is a known issue that can lead to complications like hyperglycemia, prolonged recovery, nausea, vomiting, pain, surgical site infections, and longer hospital stays. The study aims to investigate whether BCAA preloading before surgery can help reduce these risks more effectively than carbohydrate preloading or fasting and to evaluate the effects of preloading with Branched Chain Amino Acids compared to carbohydrate preloading and conventional fasting on postoperative insulin resistance and hyperglycemia in patients undergoing elective laparoscopic cholecystectomy. The trial will take place at the All India Institute of Medical Sciences (AIIMS) in Gorakhpur, India, and will span over two years. The first 18 months will focus on enrolling patients, carrying out interventions, and conducting follow-up assessments, while the final 6 months will be dedicated to data analysis and report writing. During this period, adult patients who are scheduled for elective laparoscopic cholecystectomy that satisfy inclusion criteria and does not meet the exclusion criteria will be enrolled. Participants will be randomly assigned to one of three groups: Branched Chain Amino Acids, Carbohydrate, or Conventional fasting. The study will assess the impact on various postoperative outcomes, including insulin resistance, hyperglycemia, postoperative nausea and vomiting, pain, surgical site infections , recovery of bowel function, and length of hospital stay.By comparing these three approaches, the study aims to determine whether BCAA preloading can improve post-surgical recovery by mitigating insulin resistance and hyperglycemia, ultimately leading to fewer complications and a quicker recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients aged 18 years and older 2.Patients scheduled for elective laparoscopic cholecystectomy 3.BMI within 18.5 – 29.9 kg/m2 4.ASA – PS Classification I or II 5.Willingness to comply with study protocols, including preoperative fasting & BCAA and carbohydrate administration 6.Patients who provide informed consent to participate in the study.
排除标准
- •1.Patients with pre-existing metabolic disorders like Diabetes, Obesity or any systemic illness that affects Glucose metabolism 2.Previous history of surgery on the oesophagus or stomach 3.Patients with symptoms related to severe GERD or Hiatal hernia 4.Patients with abnormal fasting blood glucose (more than 110 mg/dl)or insulin levels(more than 24.9 U/ml) prior to surgery 5.Chronic Liver Disease /Chronic Kidney Disease /Chronic Endocrine disorders that may affect glucose or amino acid metabolism 6.Pregnant or Breast-Feeding women 7.Use of Insulin/OHA/Medications affecting glucose metabolism within recent period 8.Use of Protein/Amino acid supplements within recent period 9.Conversion to open surgery and bail out procedure will be excluded 10.Patients with cognitive impairment or inability to provide informed consent.
结局指标
主要结局
To study the effect of Pre-operative Branched Chain Amino Acid Overloading on Post-operative Insulin Resistance and Post-Operative Hyperglycaemia in patients undergoing elective laparoscopic cholecystectomy. The primary endpoint will be the successful demonstration of effect of BCAA preloading compared to carbohydrate overloading and conventional overnight fasting on Post-operative Insulin Resistance and post-operative hyperglycaemia
时间窗: Primary Outcomes will be assessed 12-15 hours before surgery, 1 hour before induction of anesthesia on day of surgery and post operatively on 10th Hour after completion of surgery
次要结局
- Assess the Incidence of hyperglycaemia related complications such as Post Operative Hunger, Thirst , Anxiety, Fatigue, Post Operative Nausea & Vomiting ,Prolonged Hospital Stay, Post Operative Pain, Surgical Site Infection, Bowel function recovery(All patients will be followed in post operative period on Day 0 Day 1 Day 2 at time of discharge & at 90 days post surgery.)
研究者
Dr Baddala Santhosh Reddy
All India Institute of Medical Sciences Gorakhpur