Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery

Not Applicable

Recruiting

• Conditions: Carbohydrate; Major Abdominal Surgery; Fasting

• Registration Number: NCT06243367
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to compare the effect of preoperative carbohydrate load versus the fasting protocol in patients undergoing major abdominal operations.

Detailed Description

The surgical patients are influenced by many stressors during operation such as the prolonged fasting hours. Importantly, these stressors are iatrogenic and have been shown to disturb homeostasis with little benefit. Surgery itself, induces an endocrine and inflammatory stress response and contributes to postoperative insulin resistance (PIR) which increased also by Preoperative fasting.

Postoperative insulin resistance is a state of reduced insulin-mediated glucose uptake in skeletal muscles and adipose tissue, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia.

Strategies to reduce the postoperative stress response and postoperative insulin resistance include shortening the preoperative fasting time via preoperative carbohydrate oral drink administration (carbohydrate load). Preoperative fasting is the first step in postoperative insulin resistance development. The traditional fasting time of 6-8 h before elective surgery to prevent pulmonary aspiration usually extends up to 12 h in anesthetic practice. Overnight fasting is a physiological state of reduced insulin sensitivity due to the normal hormonal diurnal rhythm. If patients undergo surgery in the prolonged fasted state, insulin resistance may begin even before surgery.

A preoperative carbohydrate drink acts as a morning meal, may improve insulin sensitivity and propel the patient's metabolic state towards anabolism. The rationale of this study is to compare the differences between preoperative CHO loading and a conventional fasting protocol on the postoperative insulin resistance, Glasgow prognostic score (GPS), subjective patient well-being and surgical clinical outcome.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2024-01-14
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Age from 21 and 70 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status l & ll.
• Scheduled for elective major abdominal surgery

Exclusion Criteria

• Disseminated malignant disease.
• Increased risk for gastric content aspiration.
• Body Mass Index (BMI) below 20 or above 30 kg/m2.
• Nutritional risk screening 2002 score above 3.
• Emergency surgery, diabetic patients, immunomodulatory therapy.
• Refusal of the patient.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The metabolic response	5 days postoperatively	The patient was also subjected to further assessment by bioelectrical impedence analysis for measuring of the basal body muscle mass preoperatively and 5 days postoperatively.

Secondary Outcome Measures

Name	Time	Method
Postoperative discharge day	27 days postoperatively	Postoperative discharge day will be recorded.
Time of independent ambulation	27 days postoperatively	Time of independent ambulation will be recorded.
The postoperative inflammatory response	First day postoperative	Postoperative inflammatory response was assessed at 6 o'clock A.M on the day of surgery (T1, basal value), 6 h after surgery (T2), at 6 o'clock A.M on postoperative day 1 (T3) .
Complications	24 hours postoperatively	Complications such as nausea and vomiting were assessed preoperatively and at intervals 4, 8, 12, and 24 hours postoperatively

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt