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

NCT ID: NCT06243367

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-04-01

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.

Conditions

Carbohydrate; Fasting; Major Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fast (Control) group

Patients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery

Group Type: PLACEBO_COMPARATOR

Placebo drink

Intervention Type: OTHER

Patients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery

Carbohydrate group

Patients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved.

Group Type: EXPERIMENTAL

Carbohydrate

Intervention Type: DIETARY_SUPPLEMENT

Patients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved.

Interventions

Placebo drink

Patients were instructed to be fasting for 6 hours before surgery and received only placebo drink (200 ml clear water) two hours before surgery

Intervention Type: OTHER

Carbohydrate

Patients were given a meal of cup of yogurt (100 ml) with 2 spoonful of honey (42 gm) at midnight before surgery and 200 ml of a clear carbohydrate drink on the day of surgery, 2 h before anesthesia induction. This drink consisted of 200 ml water in which two spoonful of honey were dissolved.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Eman Mohammed Taher Salem Abo-Omar

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Eman M AboOmar, Master

Role: CONTACT

emantaher6669@gmail.com

00201090822808

Facility Contacts

Eman M Abo-Omar, Master

Role: primary

emantaher6669@gmail.com

00201090822808

Other Identifiers

35129/12/21

Identifier Type: -

Identifier Source: org_study_id