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

Randomized Controlled Study of Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Major Abdominal Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Fasting; Major Abdominal Surgery; Carbohydrate
• Intervention / Treatment: Other: Placebo drink; Dietary supplement: Carbohydrate

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 Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eman M AboOmar, Master; Phone Number: 00201090822808; Email: emantaher6669@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Sub-Investigator: Taysser M Abdalraheem, MD
      • Contact: Eman M Abo-Omar, Master; Phone Number: 00201090822808; Email: emantaher6669@gmail.com
      • Sub-Investigator: Sohair M Soliman, MD
      • Sub-Investigator: Naglaa K Yousef, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Other: 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
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The metabolic response	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.	5 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The postoperative inflammatory response	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) .	First day postoperative
Complications	Complications such as nausea and vomiting were assessed preoperatively and at intervals 4, 8, 12, and 24 hours postoperatively	24 hours postoperatively
Time of independent ambulation	Time of independent ambulation will be recorded.	27 days postoperatively
Postoperative discharge day	Postoperative discharge day will be recorded.	27 days postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 35129/12/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No