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

Fasting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06243367
• Other study ID #: 35129/12/21
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: Eman M AboOmar, Master
• Phone: 00201090822808
• Email: emantaher6669[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carbohydrate
• Fasting
• Major Abdominal Surgery

Intervention

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

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.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Complications	Complications such as nausea and vomiting were assessed preoperatively and at intervals 4, 8, 12, and 24 hours postoperatively	24 hours postoperatively
Secondary	Time of independent ambulation	Time of independent ambulation will be recorded.	27 days postoperatively
Secondary	Postoperative discharge day	Postoperative discharge day will be recorded.	27 days postoperatively