"A Randomized Controlled Trial on the Effect of Preoperative Carbohydrate Loading in Diabetic and Non-Diabetic Patients Undergoing Elective Abdominal Surgery"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Preoperative Gastric Residual Volume Measured by Ultrasound
研究概览
简要总结
This study evaluates the effect of preoperative carbohydrate loading on early postoperative recovery in patients with type 2 diabetes mellitus undergoing elective abdominal surgery. Traditionally, patients fast before surgery, which can increase insulin resistance, delay recovery, and worsen postoperative outcomes. Preoperative carbohydrate drinks may reduce surgical stress and improve recovery, but concerns exist regarding blood glucose control and gastric emptying in diabetic patients.
In this randomized, double-blind clinical trial, 120 eligible patients will be assigned to three groups: nondiabetic control, nondiabetic with carbohydrate load, and diabetic with carbohydrate load. Patients will receive either a carbohydrate-rich drink or control solution before surgery. Preoperative gastric residual volume will be measured using ultrasound to assess aspiration risk. Blood glucose levels will be measured before and after carbohydrate intake. Postoperative outcomes including metabolic and inflammatory response, nausea and vomiting, length of hospital stay, and time to independent ambulation will be recorded.
The study aims to determine whether preoperative carbohydrate loading is safe and beneficial for diabetic patients undergoing elective abdominal surgery.
详细描述
This prospective randomized controlled double-blinded study will be conducted at Tanta University Hospitals from June 2024 to June 2025. A total of 120 adult patients (aged 21-65 years, ASA I-II) undergoing elective abdominal surgery will be enrolled. Patients will be randomly assigned to one of three groups: nondiabetic control, nondiabetic carbohydrate load, or diabetic carbohydrate load.
The primary outcome is preoperative gastric residual volume measured by ultrasound. Secondary outcomes include postoperative metabolic and inflammatory response, perioperative blood glucose levels, incidence of nausea and vomiting, length of hospital stay, and time to independent ambulation.
Patients will receive a standardized preoperative meal of yogurt and honey at midnight, with either a clear carbohydrate drink or water administered two hours before anesthesia induction. Gastric ultrasound will be performed pre-induction to assess aspiration risk. Standard general anesthesia protocols will be used, and all patients will be monitored perioperatively.
Ethical approval has been obtained, and informed consent will be collected from all participants. Data confidentiality and patient privacy will be strictly maintained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 21-65 years
- •Both males and females
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Scheduled for elective abdominal surgery under general anesthesia
- •Able and willing to provide informed consent
排除标准
- •Patient refusal
- •Known liver or renal pathology affecting gastric function
- •Mental dysfunction or cognitive disorders impairing consent or cooperation
- •Increased risk of gastric content aspiration
- •Body mass index (BMI) < 20 or > 35 kg/m²
- •Prior upper gastrointestinal surgery
- •Use of medications affecting gastric motility
- •Type 1 diabetes mellitus
- •Type 2 diabetes mellitus treated with insulin
- •Patients with clinical evidence of diabetic gastropathy or autonomic dysfunction
研究组 & 干预措施
Group I - Nondiabetic Control
Yogurt + honey at midnight, 200 ml water 2h pre-op
干预措施: Standard Preoperative Fasting With Water (Behavioral)
Group II - Nondiabetic CHO
Yogurt + honey at midnight, 200 ml carbohydrate drink 2h pre-op
干预措施: Preoperative Oral Carbohydrate Loading (Behavioral)
Group III - Diabetic CHO
Yogurt + honey at midnight, 200 ml carbohydrate drink 2h pre-op
干预措施: Preoperative Oral Carbohydrate Loading (Behavioral)
结局指标
主要结局
Preoperative Gastric Residual Volume Measured by Ultrasound
时间窗: Preoperative (immediately before induction of anesthesia)
Gastric residual volume (GRV) will be assessed preoperatively using gastric ultrasound examination in the right lateral position. Cross-sectional area measurements will be used to calculate gastric volume using a validated formula. This outcome evaluates gastric emptying and aspiration risk prior to anesthesia induction.
次要结局
- Postoperative Metabolic and Inflammatory Response (Glasgow Prognostic Score)(Postoperative period (within 24 hours after surgery))
- Perioperative Random Blood Glucose Levels(Preoperative and 6 hours after carbohydrate loading)
- Incidence of Postoperative Nausea and Vomiting (PONV)(Within 24 hours postoperatively)
- Length of Hospital Stay(From surgery until discharge (up to 7 days))
- Time to Independent Ambulation(Within the first 48 hours postoperatively)
研究者
Ibrahim Abdelbaset Abdelkhalik
Principal Investigator
Tanta University