Elective Abdominal Surgery, Gastric Emptying, Postoperative Recovery, Type 2 Diabetes Mellitus
Conditions
Keywords
Preoperative carbohydrate loading, ERAS, gastric residual volume, gastric ultrasound, perioperative glycemic control
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALStandard Preoperative Fasting With Water
Participants receive 100 ml yogurt mixed with approximately 42 g honey at midnight before surgery. Two hours before induction of anesthesia, they receive 200 ml of clear water. No carbohydrate-rich clear drink is administered preoperatively. This represents the standard preoperative fasting protocol used in the control group.
BEHAVIORALPreoperative Oral Carbohydrate Loading
Participants receive 100 ml yogurt mixed with approximately 42 g honey at midnight before surgery. Two hours before induction of anesthesia, they receive 200 ml of a clear carbohydrate drink consisting of 200 ml water with two spoonfuls (approximately 42 g) of honey dissolved. This intervention is administered preoperatively to reduce perioperative insulin resistance and improve metabolic response.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Gastric Residual Volume Measured by Ultrasound | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Metabolic and Inflammatory Response (Glasgow Prognostic Score) | Postoperative period (within 24 hours after surgery) | The postoperative inflammatory and metabolic response will be assessed using the Glasgow Prognostic Score (GPS), based on C-reactive protein and serum albumin levels. |
| Perioperative Random Blood Glucose Levels | Preoperative and 6 hours after carbohydrate loading | Random blood glucose (RBG) levels will be measured at three time points: before carbohydrate loading, 2 hours pre-induction, and 6 hours after carbohydrate administration. |
| Incidence of Postoperative Nausea and Vomiting (PONV) | Within 24 hours postoperatively | Occurrence of nausea and/or vomiting within the first 24 hours after surgery. |
| Length of Hospital Stay | From surgery until discharge (up to 7 days) | Total number of days from surgery until hospital discharge. |
| Time to Independent Ambulation | Within the first 48 hours postoperatively | Time required for the patient to achieve independent ambulation following surgery. |
Countries
Egypt
Outcome results
None listed